Category: 8. Health

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  • Treatment with Batten-1 seen to slow vision loss in real-world study

    Treatment with Batten-1 seen to slow vision loss in real-world study

    Treatment for approximately one year with Batten-1 (miglustat) — an experimental oral small molecule developed by Theranexus — in individuals with juvenile Batten disease, also known as CLN3 disease, resulted in significantly slower vision loss compared with untreated patients, according to new data from a real-world study.

    The findings align with those from an open-label Phase 1/2 clinical study (NCT05174039), sponsored by the Beyond Batten Disease Foundation, which was followed by an expanded access program that allowed patients to continue using the medication. After about two years, Batten-1 had helped preserve visual acuity, those results showed.

    The real-world study compared 11 patients treated with Batten-1 in routine clinical settings to 22 untreated patients, using data gathered from natural history studies, family interviews, and medical records.

    “We are deeply grateful to the patients, their families, and the healthcare providers who made this important analysis possible by agreeing to share their experiences and those unique clinical data,” Craig Benson, the foundation’s chairman, said in a press release from Theranexus that detailed the findings.

    “This collaboration has been essential in demonstrating Batten-1 potential to change the course of CLN3 disease,” Benson said.

    Recommended Reading

    Juvenile Batten disease is caused by mutations in the CLN3 gene, which encodes battenin, a protein involved in recycling molecules within cells. When battenin is missing or faulty, fatty molecules build up in lysosomes, the cell’s recycling centers. Nerve cells are especially vulnerable to this toxic buildup, which leads to the disease’s symptoms.

    Batten-1 works by inhibiting an enzyme called glucosylceramide synthase, which is involved in the production of certain fatty molecules. By blocking this enzyme, Batten-1 is expected to reduce the toxic buildup of fatty molecules in nerve cells, potentially helping to ease or prevent symptoms of juvenile Batten disease.

    Phase 3 study now planned to test therapy in juvenile Batten disease

    In the earlier Phase 1/2 clinical study, six adults and adolescents were treated for as long as about two years with Batten-1 as oral capsules at a maximum daily dose of 600 mg. In addition to preserving visual acuity, Batten-1 also prevented worsening of motor symptoms, data showed. Batten-1 was well tolerated and there were no observed serious side effects.

    After reviewing the data, regulators in both the U.S. and the European Union approved the design of a Phase 3 clinical study that will test an oral solution of Batten-1 against a placebo. It will enroll an estimated 60 children and adolescents with juvenile Batten disease.

    In the real-world study, the main endpoint was assessing changes in visual acuity or a person’s ability to recognize fine details. This was estimated using a logMAR chart consisting of rows of increasingly smaller letters. On this chart, a lower score means better vision. This is the same endpoint as that selected for the planned Phase 3 clinical study.

    Achieving near stabilization of visual acuity over 12 months in CLN3 patients is truly remarkable and unprecedented. … These results offer real hope for altering the natural progression of the disease.

    Only patients who started with some measurable vision — a LogMAR score of 1.9 or less — were tested, and were followed for one year. To ensure a fair comparison, the researchers used propensity score matching, a statistical method that accounts for differences, such as age or disease severity, between groups.

    Patients treated with Batten-1 maintained better visual acuity than untreated patients, with differences that were both statistically significant and clinically meaningful, according to Theranexus.

    “These findings strongly support our development strategy and reinforce the relevance of our endpoint in demonstrating Batten-1 potential efficacy,” said Marie Sebille, MD, Theranexus’ chief medical officer.

    For Gary Clark, MD, who’s been involved in testing Batten-1 at the Baylor College of Medicine in Houston, “achieving near stabilization of visual acuity over 12 months in CLN3 patients is truly remarkable and unprecedented. In this population, we would typically expect a relentless decline in vision. These results offer real hope for altering the natural progression of the disease.”

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  • Morphic Medical Announces CE Mark for RESET® Endoscopic Device Therapy

    Morphic Medical Announces CE Mark for RESET® Endoscopic Device Therapy

    RESET® is a minimally invasive, endoscopic, outpatient procedure designed to reduce weight and improve cardiometabolic health conditions such as Type 2 Diabetes.

    BOSTON, July 7, 2025 /PRNewswire/ — Morphic Medical, creator of the world’s first medical device designed to target the underlying cause of obesity and type 2 diabetes, today announced CE (Conformité Européenne) Mark approval for the RESET® System designed to provide patients living with obesity and metabolic disorders such as Type 2 Diabetes (T2D) with the first incision-free, endoscopic solution for immediate weight reduction and metabolic improvement. The CE Mark designation ensures RESET has met all European Commission safety, health and environmental protection requirements. The certification of RESET enables commercial launch in the European Union (EU) and other geographies that recognize CE marking.

    Many patients with obesity and T2D have poor glycemic control despite diet, lifestyle management, and medications. Although Roux-en-Y gastric bypass can be highly effective, it is an invasive and irreversible surgical procedure. RESET is a novel duodenal-jejunal bypass liner (DJBL) which is implanted endoscopically into the upper part of the small intestine, left in place for up to 9 months, and then removed endoscopically. The liner provides a physical barrier between receptors in the intestinal wall and food which has shown weight reduction and improved metabolic conditions by enhancing the guts natural hormones similar to GLP1 pharmacotherapy.

    A UK study by Dr Bob Ryder of the Sandwell and West Birmingham NHS Trust reported treatment with RESET in people living with diabetes and obesity that demonstrated an average 17.4 Kg reduction in weight and a considerable improvement in blood glucose levels (average HbA1c reduced from 9.1% to 7.2%) a 1.9% reduction, alongside improvements in blood pressure and cholesterol which reduces cardiovascular risk. The amount of insulin required by the patients also reduced considerably with 37% discontinuing insulin use altogether. The RESET procedure also demonstrated encouraging durability data three years after treatment with 77% of patients maintaining their improvements in both reduction of weight and HbA1c.1

    Joseph Virgilio, President and CEO of Morphic Medical, stated, “This critical regulatory milestone is an important step toward delivering on our promise and accomplishing our mission to alleviate the symptoms of obesity and metabolic disorders such as T2D for patients fighting these global epidemics. We’re excited to help patients who have failed to achieve their goals through a program of diet, exercise, and medical management, and are looking for an alternative therapy.” He added that, “Regulatory approval under EU MDR allows us to immediately offer RESET to the millions of patients suffering from uncontrolled obesity and cardiometabolic disorders throughout Europe.”

    Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) says, “RESET is a non-surgical, endoscopic sleeve that lines the upper intestine to mimic some physiological effects of gastric bypass—boosting GLP-1, reducing insulin resistance, and improving blood sugar and weight control. It offers a less-invasive option for people with type 2 diabetes and obesity who haven’t responded well to medications or need a “bridge” before bariatric surgery.”

    The RESET System is intended to be used as an adjunct therapy to lifestyle and/or medication(s) for the management of morbid obesity and/or obesity in the presence of at least one concurrent cardiometabolic risk factor, e.g., type 2 diabetes and/or dyslipidemia. It is also intended to prevent contact of ingested nutrients with the mucosal lining of the duodenum and proximal jejunum (via the RESET Liner) in patients described above in order to promote weight loss, weight-loss mediated glycemic control and to minimize the likelihood of obesity-related complications such as cardiovascular disease and/or deterioration of underlying type 2 diabetes. RESET is indicated for a maximum implant duration of nine months.

    1. Ryder et al. Duodenal-jejunal bypass liner for treatment of T2DM and obesity: 4-year outcomes in the first National Health Service (NHS) EndoBarrier service. British Journal of Diabetes 2022.

    About Morphic
    Morphic Medical is the developer of RESET, an endoscopically delivered therapy which offers a non-surgical, alternative treatment for morbid obesity and/or obesity in the presence of concurrent cardiometabolic risk factor, e.g., type 2 diabetes and/or dyslipidemia. RESET is not approved for sale in the United States and is limited by federal law to investigational use only. Founded in 2003, Morphic Medical is headquartered in Boston, Massachusetts. For more information, please visit morphicmedical.com or follow us on Twitter and LinkedIn.

    Morphic Medical Media Contact:
    Investor Relations
    [email protected]
    +1 (781) 357-3296

    SOURCE Morphic Medical


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  • ACE inhibitor deemed cause of intestinal angioedema in woman, 39

    ACE inhibitor deemed cause of intestinal angioedema in woman, 39

    A woman in her 30s who experienced recurrent, nonspecific gastrointestinal symptoms was diagnosed with angioedema of the small intestine — also known as intestinal angioedema, or sometimes angioedema of the bowel — related to the use of an angiotensin-converting enzyme (ACE) inhibitor to treat high blood pressure, according to a case report.

    The woman’s symptoms eased after stopping treatment with the medication, lisinopril, with no recurrence of angioedema attacks, or sudden swelling in the skin, after three months, the researchers noted.

    “The information provided is intended to assist health care professionals in recognizing clues associated with angioedema of the small intestine, allowing timely diagnosis and effective treatment for patients with [intestinal] angioedema,” the researchers wrote.

    The case report, “Recognizing Clues Associated With Angioedema of the Small Intestine: A Case Report,” was published in the Journal of Emergency Nursing by two nursing professors at The University of Tampa.

    Recommended Reading

    Angioedema is a condition marked by swelling in the deeper layers of the skin or mucus membranes. Drug-induced nonallergic angioedema is an adverse effect of certain medications — most commonly, angiotensin-converting enzyme (ACE) inhibitors. These drugs are often used to treat people with high blood pressure, or hypertension, and other cardiovascular conditions.

    ACE inhibitors usually cause angioedema in the face, lips, tongue, or throat, leading to swelling and sometimes blocked airways. But it’s less well known that they can also cause swelling in the small intestine.

    Diagnostic journey detailed for woman with intestinal angioedema

    Here, a research team in Florida described the diagnostic journey of a 39-year-old woman who sought emergency department treatment for mild to severe abdominal pain that had started two days earlier. She had a history of several months of intermittent nonspecific gastrointestinal symptoms, such as abdominal pain, loss of appetite, bloating, nausea, vomiting, frequent burping, and diarrhea.

    She also had hypertension, for which she was treated, for five years, with hydrochlorothiazide, a diuretic, and lisinopril, an ACE inhibitor. The woman also reported having experienced one episode of mild lip and facial swelling two months earlier, which was effectively treated with antihistamines and corticosteroids.

    Following that episode, she was referred to an allergist, who found that her C1 esterase inhibitor (C1-INH) activity was normal. This ruled out hereditary angioedema, which is typically caused by low levels or impaired function of C1-INH. In such cases, excess bradykinin accumulates, leading to blood vessel dilation, fluid leakage, and swelling

    Besides abdominal symptoms, a physical examination indicated the abdomen was slightly distended, with generalized tympany — a percussion sound when tapping due to the accumulation of air and gas throughout the abdomen, which may indicate a bowel condition — and discomfort/pain when light pressure was applied.

    A CT scan also revealed swelling in a region of the small bowel with inflammation signs. This was suggestive of a bowel condition, such as an inflammatory disease or infection, or a mechanical obstruction. Ischemia, or a lack of blood flow to a part of the bowel, can also cause these symptoms.

    Laboratory analysis indicated a moderate increase in the levels of leucocytes, or white blood cells, which could indicate an inflammatory or infectious process.

    Clinicians started the woman on treatment with intravenous, or into-the-vein, morphine, which effectively controlled her abdominal pain, and intravenous haloperidol for nausea and vomiting. Her condition improved, and she was discharged with no adjustments to her medication or additional recommendations.

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    Woman’s abdominal symptoms resolved after stopping ACE inhibitor

    Two weeks later, however, she returned to the emergency department with the same symptoms, as well as bowel inflammation signs in the CT scan. She was referred to a specialist in gastrointestinal conditions, who suspected ACE inhibitor-induced angioedema and immediately discontinued lisinopril.

    The woman’s abdominal symptoms completely resolved after three days, according to the report.

    “Even though the exact pathogenetic [disease-causing] mechanism of ACE inhibitor-induced angioedema is not fully understood, current research posits that the inhibitory actions of these medications prevent the breakdown of bradykinin,” the researchers wrote.

    [This] case report underscores the challenges health care providers face in diagnosing [intestinal] angioedema and the crucial role of emergency nurses in recognizing key warning signs such as nonspecific abdominal complaints in patients on angiotensin-converting enzyme [ACE] inhibitor therapy.

    The team reported that several medications the woman subsequently used to control blood pressure triggered similar symptoms. After further adjustments, the patient’s blood pressure was well controlled with triamterene/hydrochlorothiazide, nebivolol, and amlodipine. The woman remained free from previous abdominal symptoms for at least three months, per the report.

    According to the researchers, “[this] case underscores the challenges health care providers face in diagnosing [intestinal] angioedema and the crucial role of emergency nurses in recognizing key warning signs such as nonspecific abdominal complaints in patients on angiotensin-converting enzyme [ACE] inhibitor therapy.”

    “Early identification of this condition can prevent unnecessary procedures, prevent prolonged symptoms, and improve patient outcomes,” the team added.

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  • Researchers in Sweden identify 18 new potential MS drug targets

    Researchers in Sweden identify 18 new potential MS drug targets

    Researchers at the Karolinska Institute in Sweden said they have identified 18 new potential protein drug targets to treat multiple sclerosis (MS) using an integrative analytical approach.

    A drug target is a molecule, typically a protein, within the body that’s often involved in disease processes. Some of the newly discovered proteins are targeted by existing non-MS drugs, suggesting these therapies may be repurposed to treat MS.

    The discovery was reported in the study, “Multiomics integration prioritizes potential drug targets for multiple sclerosis,” published in the Proceedings of the National Academy of Sciences.

    “Our results demonstrate significant potential for both the discovery of new drugs and the repurposing of existing ones,” Yuan Jiang, a PhD candidate at the Karolinska Institute and the study’s first author, said in a university news story.

    MS is marked by inflammatory damage to healthy parts of the brain and spinal cord. While several disease-modifying therapies (DMTs) are available to manage the disease by reducing the frequency and severity of relapses and delaying disability progression, more effective therapies are needed, especially for people with progressive forms of MS.

    Recommended Reading

    Identifying proteins, looking for roles in MS

    “Continuous exploration of drug discovery, development, and repurposing has become increasingly crucial for improving both the efficacy and the safety of MS treatment,” the researchers wrote.

    To identify candidate proteins linked to MS, the Karolinska researchers first conducted a proteome-wide association study (PWAS), a method that looks for relationships between protein levels in the blood and brain and MS susceptibility. Here, 100 proteins in the blood and 212 proteins in brain tissue had levels that were significantly associated with MS susceptibility.

    A technique called summary-data-based Mendelian randomization was then used to determine whether any of the proteins identified by PWAS played a causal role in MS. Overall, nine blood and nine brain proteins were considered causal and thus potential drug targets.

    Among the blood proteins, CR1 and WARS were associated with an increased risk of MS, whereas TNFRSF1A, FCRL3, TYMP, PGLYRP1, CD59, IDUA, and ARHGAP1 were linked with a reduced risk of MS. In the brain, HLA-B, ZC2HC1A, HMGCL, TSFM, FAM120B, TRAF3, and MTHFR were tied to an increased risk of MS, while ICA1L and AUH were associated with a decreased MS risk.

    Further experiments revealed that blood proteins were mostly produced by immune cells involved in MS, while brain proteins were mostly sourced to nerve cells and other supportive brain cells such as oligodendrocytes, the cells that produces myelin in the brain and spinal cord, astrocytes, and blood vessel cells.

    A subsequent analysis found that five of the nine blood drug targets interacted with 19 known targets of 10 approved MS medications. Likewise, two of the nine brain drug targets interacted with five known drug targets of six MS therapies.

    Four of the blood-based targets and two brain-based targets were also targeted by 16 existing drugs not used in MS, “suggesting potential opportunities for drug repurposing,” the team wrote.

    “By integrating large-scale … data and applying advanced statistical methods, we have been able to prioritize drug targets that may improve the treatment of MS,” Jiang said.

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  • 5 serious diseases Vitamin D deficiency can cause

    5 serious diseases Vitamin D deficiency can cause

    Vitamin D is much needed for bone health, supporting immunity, regulating mood, and inflammation– thus making it important for our overall health and well-being. Apart from getting it from foods, Vitamin D is also synthesised in the body when exposed to sunlight and hence it is also called the “sunshine vitamin”. However, a large number of people across the world suffer from Vitamin D deficiency, often without even knowing it. This deficiency is mainly due to poor diets and limited sun exposure, and it can lead to more than just fatigue or low mood— it’s been linked to several serious health issues, some of which can be long-term or even life-threatening if ignored. Here we list some serious diseases Vitamin D deficiency can cause:


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  • New study challenges what we know about the biology of ageing

    New study challenges what we know about the biology of ageing

    For years, scientists have believed that inflammation inevitably increases with age, quietly fuelling diseases like heart disease, dementia and diabetes. But a new study of Indigenous populations challenges that idea and could reshape how we think about ageing itself.

    For decades, scientists have identified chronic low-level inflammation – called “inflammaging” – as one of the primary drivers of age-related diseases. Think of it as your body’s immune system stuck in overdrive – constantly fighting battles that don’t exist, gradually wearing down organs and systems.

    But inflammaging might not be a universal feature of ageing after all. Instead, it could be a byproduct of how we live in modern society.

    The research, published in Nature Aging, compared patterns of inflammation in four very different communities around the world. Two groups were from modern, industrialised societies – older adults living in Italy and Singapore.

    The other two were Indigenous communities who live more traditional lifestyles: the Tsimane people of the Bolivian Amazon and the Orang Asli in the forests of Malaysia.

    The researchers analysed blood samples from more than 2,800 people, looking at a wide range of inflammatory molecules, known as cytokines. Their goal was to find out whether a pattern seen in earlier studies – where certain signs of inflammation rise with age and are linked to disease – also appears in other parts of the world.

    Among the Italian and Singaporean participants, the researchers found a fairly consistent inflammaging pattern

    Among the Italian and Singaporean participants, the researchers found a fairly consistent inflammaging pattern (Getty Images)

    The answer, it turns out, is both yes and no.

    Among the Italian and Singaporean participants, the researchers found a fairly consistent inflammaging pattern. As people aged, levels of inflammatory markers in the blood, such as C-reactive protein and tumour necrosis factor, rose together. Higher levels were linked to a greater risk of chronic diseases including kidney disease and heart disease.

    But in the Tsimane and Orang Asli populations, the inflammaging pattern was absent. The same inflammatory molecules did not rise consistently with age, and they were not strongly linked to age-related diseases.

    In fact, among the Tsimane, who face high rates of infections from parasites and other pathogens, inflammation levels were often elevated. Yet this did not lead to the same rates of chronic diseases that are common in industrialised nations.

    Despite high inflammatory markers, the Tsimane experience very low rates of conditions such as heart disease, diabetes and dementia.

    Inflammaging may not be universal

    These results raise important questions. One possibility is that inflammaging, at least as measured through these blood signals, is not a universal biological feature of ageing. Instead, it may arise in societies marked by high-calorie diets, low physical activity and reduced exposure to infections.

    In other words, chronic inflammation linked to ageing and disease might not simply result from an inevitable biological process, but rather from a mismatch between our ancient physiology and the modern environment.

    The study suggests that in communities with more traditional lifestyles – where people are more active, eat differently and are exposed to more infections – the immune system may work in a different way. In these groups, higher levels of inflammation might be a normal, healthy response to their environment, rather than a sign that the body is breaking down with age.

    Another possibility is that inflammaging may still occur in all humans, but it might appear in different ways that are not captured by measuring inflammatory molecules in the blood. It could be happening at a cellular or tissue level, where it remains invisible to the blood tests used in this research.

    Why this matters

    If these findings are confirmed, they could have significant consequences.

    First, they challenge how we diagnose and treat chronic inflammation in ageing. Biomarkers used to define inflammaging in European or Asian populations might not apply in other settings, or even among all groups within industrialised nations.

    Second, they suggest that lifestyle interventions aimed at lowering chronic inflammation, such as exercise, changes in diet, or drugs targeting specific inflammatory molecules, might have different effects in different populations. What works for people living in cities might be unnecessary, or even ineffective, in those living traditional lifestyles.

    Lifestyle interventions aimed at lowering chronic inflammation might have different effects in different populations

    Lifestyle interventions aimed at lowering chronic inflammation might have different effects in different populations (PA)

    Finally, this research serves as an important reminder that much of our knowledge about human health and ageing comes from studies conducted in wealthy, industrialised nations. Findings from these groups cannot automatically be assumed to apply worldwide.

    The researchers are clear: this study is just the beginning. They urge scientists to dig deeper, using new tools that can detect inflammation not just in the blood, but within tissues and cells where the real story of ageing may be unfolding. Just as important, they call for more inclusive research that spans the full range of human experience, not just the wealthy, urbanised corners of the world.

    At the very least, this study offers an important lesson. What we thought was a universal truth about the biology of ageing might instead be a local story, shaped by our environment, lifestyle and the way we live.

    Samuel J. White is an Associate Professor & Head of Projects at York St John University. Philippe B. Wilson is an Associate Pro Vice-Chancellor: Innovation and Knowledge Exchange at York St John University.

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Unexpected Gains in Batten Disease Treatment

    Unexpected Gains in Batten Disease Treatment

    June 2025 marks one year since Amelia and Makenzie Kahn received their first dose of Zebronkysen, a personalized treatment developed by University of Michigan, Michelle Hastings, PhD, for their specific mutation associated with juvenile Batten disease, or CLN3. So far, benefits of the drug have helped Makenzie walk farther on her own while Amelia is taking bites of food, including ice cream.

    Batten disease is an inherited, fatal pediatric neurodegenerative disorder in which patients experience loss of abilities; from motor, communication and cognitive decline to vision loss. They also suffer from seizures, anxiety, pain, and systemic effects, such as feeding and breathing difficulties. Life expectancy is from the teenage years to early twenties.

    Yael Shiloh-Malawsky, MD

    The ForeBatten Foundation, a nonprofit that was founded in 2017, funds juvenile Batten disease research and support for families whose lives have been affected by the disease. In June 2024 it launched the “N-of-2” clinical trial: the first in human RNA treatment tailored to a rare mutation of CLN3. The trial is the culmination of investigational drug development efforts, from laboratory research to manufacturing to establishing a trial protocol, with UNC serving as the study site. Yael Shiloh-Malawsky, MD, a professor of neurology at the UNC School of Medicine, leads the clinical study.

    This new type of personalized trial, frequently referred to as an “N-of-1” study, is a type of clinical trial that focuses on just one individual rather than a large group of people. In the case of Makenzie and Amelia, this specific treatment was created for two patients, an “N-of-2” study.

    Over the past year, Zebronkysen proved in being well-tolerated and demonstrated benefit for the girls. The drug was created to help restore the function of Amelia and Makenzie’s CLN3 gene ultra rare mutation and prevent further decline.

    Thriving in the face of Batten disease:

    Makenzie Kahn

    photo by: Caitlin O’Hara

    Makenzie’s Progress

    A step in the right direction sparked for Makenzie. From less drowsiness to walking unassisted, profound moments were seen.

    “Before the trial started one of the protocols in collecting data was to measure Makenzie’s steps as she walked for two minutes without help,” said Shiloh-Malawsky. “Before the start of the drug, she walked 22 yards and did not walk the full two minutes. Six months after receiving the treatment, she walked 48 yards.”

    Dystonia can be a symptom of Batten disease. It occurs when a patient experiences involuntary muscle contractions, spasms, pain and lack of mobility. Prior to start of the trial Makenzie’s motor abilities were severely affected by dystonia, her dystonia has greatly decreased after receiving the treatment. She also regained the ability to get out of bed and to get up from the floor with no assistance, which was not possible for more than two years before starting the drug trial.

    Makenzie’s energy level and stamina also improved, “Makenzie used to nap a lot and be sleepy. Now, she’s more alert and awake,” said Karen Kahn, Amelia and Makenzie’s mom.

    Amelia’s Progress

    Amelia Kahn

    photo by: Caitlin O’Hara

    Moments of joy appeared in Amelia and her smiles have become second nature.

    “Before the treatment Amelia experienced sensory overload with Batten,” Karen said. “Now she tolerates noise in a restaurant and is happy. She wakes up in the morning and smiles at me.”

    For the first time in about two years, Amelia started taking food and drink by mouth, like sipping water and taking bites of ice cream and yogurt. She also would normally need about two liters of oxygen to sleep at night, but now the amount has dropped to half a liter.

    “Amelia also has more energy,” said Karen. “We used to use PRN rescue meds, as needed medications to help with pain, muscle spasms, and anxiety, to calm Amelia, and now we rarely need them. We still use daily medicines for the girls but not using the rescue medicines on a daily basis is a huge deal,” she said.

    “We were pleasantly surprised by some of girls’ abilities appearing to come back,” said David Kahn, Amelia and Makenzie’s dad. “They didn’t last the complete three months between treatments, but there was the spike and plateau of benefits that we were very welcomed to see,” he said.

    A Treatment Pathway

    Amelia & Malawsky

    photo by: Caitlin O’Hara

    The girls started off receiving an intrathecal injection of 15 milligrams of Zebronkysen in June 2024. They received additional dose every three months, and the dosage was increased with a goal of seeing the progression of the disease lessen.

    “After four doses, 12 months from the first dose in June 2024, we have seen an impact that is more positive than what we expected on multiple domains,” said Shiloh-Malawsky. “Our hypothesis was that restoring CLN3 protein function would stabilize this neurodegenerative disorder and prevent further decline. We did not expect to see improvement in addition to a slowing of decline, seeing improvements is more than we hoped for.”

    Throughout the year researchers observed how abilities were temporarily regained after each dose. Symptoms improved in neurologic, psychological, and general health areas, like gastrointestinal issues, which became less severe. The positive effects appeared in multiple ways, like changes in mood, ability to tolerate noisy environments, a decrease in irritability and anxiety, and improved motor abilities. Importantly, no serious adverse events related to the study drug were observed. Increasing the drug dosage has led to longer-lasting benefits.

    In June 2025, the girls received the target high dose of 45 milligrams. As of now, that amount will be the girls’ maintenance dose. With the higher dose the study team hopes to achieve lasting and sustained benefits. Dr. Shiloh-Malawsky says as long as the girls continue to benefit from it, they will continue to receive the high dosage every three months.

    New Possibilities on the Horizon

    Makenzie & Amelia

    Makenzie and Amelia celebrate graduating from 8th grade.

    The ForeBatten Foundation, Vanguard Clinical Rare Disease Foundation (VCRDF), a team of scientists and drug developers, and the UNC team are working to raise funding to develop treatment for other mutations that cause CLN3 Batten disease, medications that could benefit a larger patient population.

    “Seeing the beneficial results from this trial puts an emphasis on the urgent need to develop similar interventions for people with other mutations in this gene of Batten disease,” said Shiloh-Malawsky.

    With Zebronkysen becoming unquestionably life-changing and researchers continuing to develop individualized investigational antisense oligonucleotides (ASOs), the science is reaching new heights and potential for treating the common mutation of CLN3.

    “We haven’t had any more loss of abilities while being on the drug over the last year,” said David. “That speaks to the stabilization of the decline of the disease. Zebronkysen looks very promising in our eyes.”

    /Public Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).View in full here.

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  • Africa: How Global Fund Is Saving Lives From Malaria, TB, & HIV Across Africa

    Africa: How Global Fund Is Saving Lives From Malaria, TB, & HIV Across Africa

    New York — In Gabú, Guinea-Bissau, a grandmother named N’beta hesitated. Her six-month-old grandson, Seco, was healthy, so why give him medicine? But community health workers Jamilia and Amadu gently explained that the medicine wasn’t for illness, but for protection. It was part of a seasonal malaria chemoprevention campaign designed to protect children during the worst malaria transmission months — the rainy season.

    “Now I understand it’s to keep him safe,” N’beta said, watching Seco become one of 250,000 children protected in 2024 with a simple but life-saving dose.

    Malaria remains a deadly threat across Africa, especially for children under five. But with support from the Global Fund to Fight AIDS, Tuberculosis and Malaria, the United Nations Development Programme (UNDP) and its partners are reaching the most vulnerable, particularly in hard-to-reach communities.

    In Chad, 9.4 million mosquito nets were distributed using a fully digitalized system in 2023, protecting 3.5 million households. In Burundi, 1.3 million people were protected through indoor spraying in 2024. In Guinea-Bissau, malaria prevalence dropped by more than half in just three years from 2020-2023.

    But malaria is only one of the threats.

    In South Sudan, tuberculosis (TB) continues to claim lives, often undetected.

    “Not everyone can read and interpret an X-ray report,” said Dr. Ofere Ohide, a Radiologist at Torit State Hospital. “But with new AI-assisted X-ray machines, even clinics without power or specialists can now detect TB early,” he says of the digital x-ray machines provided through the Global Fund support.

    These innovations, combined with decentralized care and improved case notification, helped 92% of people with TB receive treatment in 2023, contributing to a 75% drop in TB-related deaths in South Sudan since 2015. Similarly, close to 20,000 people got cured of TB out of about 23,000 TB cases registered in 2023 representing 85% treatment success rate.

    And then there’s HIV – a virus that once devastated entire generations.

    In Zimbabwe, where AIDS once slashed life expectancy to 45 years, progress has been hard-won. One young woman, Princess, 17, a survivor of sexual abuse, found strength through a Global Fund-supported comprehensive sexuality education programme delivered by UNDP and partners.

    “I reclaimed my voice and will use it to ensure justice for survivors of abuse,” she said, now dreaming of becoming a lawyer.

    In Angola, 22-year-old Ana Alexandre became a peer educator after joining sessions on sexual and reproductive health. “I am no longer ashamed to talk about sexuality,” she shared. “My little sister can come to me and ask things… I answer normally and clearly.”

    Since 2003, UNDP and the Global Fund have worked hand-in-hand with governments, civil society, and communities to end HIV, TB, and malaria, even in the most fragile settings. In Africa, countries supported by UNDP and the Global Fund include Angola, Burundi, Chad, Republic of the Congo, Democratic Republic of the Congo (DRC), Guinea-Bissau, Zimbabwe, São Tomé and Príncipe, Mozambique, and South Sudan.

    In 2023 alone:

    1.5 million people received HIV treatment

    44,000 people were treated for TB

    13.1 million mosquito nets were distributed to prevent malaria