Image credit: TAXIS Pharmaceuticals
TAXIS Pharmaceuticals announced today that it has received an FDA Qualified Infectious Disease Product (QIDP) designation for TXA14007, its investigational efflux pump inhibitor (EPI) in combination with levofloxacin for the treatment of hospital-acquired pneumonia (HAP) and ventilator associated pneumonia (VAP).1
The QIDP designation will allow the company to have access the FDA’s Fast Track program, allow for priority review, and make the compound eligible for a potential 5-year extension of market exclusivity upon approval. These advantages are designed to accelerate the development and review processes, ensuring that novel therapies can reach patients faster and address urgent public health needs efficiently. With the support of this designation, TAXIS Pharmaceuticals is poised to advance the development process for its EPIs.
“The QIDP designation is a critical milestone in our mission to deliver effective solutions against antimicrobial resistance,” TAXIS Pharmaceuticals CEO Gregory Mario, said in a statement. “Too many people are dying from infections like hospital acquired pneumonia—infections that should be treatable. We are committed to our mission because we know that lives are on the line.”1
TAXIS is a clinical-stage company developing new classes of therapies to treat multidrug-resistant bacterial infections. Their investigational drug candidates include efflux pump inhibitors, DHFRIs, and FtsZ inhibitors and aim to combat antimicrobial resistance (AMR).
Learn more: A Group of Antimicrobial Compounds Show Novelty Action Against Multidrug-Resistant Gonorrhea
The TXA 14007 class of EPIs significantly enhanced the effectiveness of levofloxacin and other antibiotics against a wide range of drug-resistant P aeruginosa strains found in clinical settings. Preclinical data on TXA14007 shows no signs of inherent toxicity and finds that it is effective in improving the action of levofloxacin in animal efficacy models.
This news marks the company’s second FDA QIDP designation. The first was granted for TXA709, the company’s first investigational FtsZ inhibitor candidate, aimed at treating antibiotic-resistant methicillin-resistant Staphylococcus aureus (MRSA). TAXIS is seeking additional funding and partnerships with drug manufacturers to continue the development and commercialization of its investigational EPIs and its broader portfolio of investigational therapies aimed at addressing the escalating burden of antimicrobial resistance.