FDA Grants Special Designation to TAXIS Pharmaceuticals Experimental Antibiotic
Compound Named a Qualified Infectious Disease Product (QIDP) for Acute Bacterial Skin and Skin Structure Infections
NORTH BRUNSWICK, N.J., Sept. 7, 2016 /PRNewswire/ -- TAXIS Pharmaceuticals, a development-stage drug-discovery company researching a new class of antibiotic agents to treat life-threatening, multidrug-resistant bacterial infections, announced today that its lead clinical candidate, TXA709, received Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration (FDA). TXA709 targets acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus, including methicillin-resistant strains.
QIDP grants TAXIS regulatory incentives including eligibility for fast track designation, priority review, and five additional years of marketing exclusivity. Created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, the QIDP designation seeks to encourage the development of new antimicrobial drugs to combat the rising threat of multidrug-resistant bacteria.
"We are delighted with the FDA's decision to grant TXA709 a Qualified Infectious Disease Product designation as we continue to research its potential," said Gregory Mario, President and Chief Executive Officer of TAXIS Pharmaceuticals. "Pre-clinical data shows TXA709 to be a promising and potentially revolutionary antibiotic."
TXA709 is a prodrug, a biologically inactive compound that can be metabolized in the body to produce a drug, TXA707, a derivative of benzoic acid that disrupts the form and function of the bacterial protein FtsZ, which plays an essential role in bacterial cell division. The inhibition of FtsZ is considered a novel mechanism of action, enhancing the appeal of TXA709 as an important tool for addressing the public health crisis stemming from the growing threat of antibiotic resistance.
About TAXIS
TAXIS Pharmaceuticals develops novel antibiotics to combat multidrug-resistant bacteria. TAXIS has identified and patented multiple new classes of proprietary antibiotic agents that exploit a novel mechanism of bactericidal action distinct from any other antibiotic in clinical use today. For more information visit www.TAXISpharma.com.
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SOURCE TAXIS Pharmaceuticals
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