TAXIS Pharmaceuticals this week announced that TXA709 was granted Qualified Infectious Disease Product (QIDP) status by the U.S. Food and Drug Administration (FDA).
TXA709 is biologically inactive, but the body metabolizes it to produce TXA707, which is derived from benzoic acid. It interferes with bacterial cell division by inhibiting FtsZ, a bacterial protein. TXA709 affects drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause acute bacterial skin and skin structure infections (ABSSSI).
"We are delighted with the FDA's decision to grant TXA709 a Qualified Infectious Disease Product designation as we continue to research its potential," TAXIS Pharmaceuticals President and CEO Gregory Mario said. "Pre-clinical data shows TXA709 to be a promising and potentially revolutionary antibiotic."
The QIDP designation was created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012. QIDP gives the manufacturer incentives to develop new antimicrobial drugs that affect multidrug-resistant bacteria. The proprietary antibiotic agent TXA709 will be eligible for fast track designation, priority review and an additional five years of marketing exclusivity.
Drug-resistant strains of bacteria are a growing problem. Approximately 23,000 people die annually from antibiotic resistant bacterial infections.