Rib-X Pharmaceuticals announced that the Food and Drug Administration (FDA) designated delafloxacin as a Qualified Infectious Disease Product (QIDP) for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
The QIDP designation will enable Rib-X to benefit from certain incentives for the development of new antibiotics, including an additional five years of market exclusivity, priority review and eligibility for fast-track status, provided under the new Generating Antibiotic Incentives Now (GAIN) program. GAIN was included in the FDA Safety and Innovation Act (FDASIA), formerly known as PDUFA V, which received bipartisan Congressional support and was signed into law by President Obama in July 2012.
Delafloxacin has been in four Phase 2 trials where it has shown promising results for the treatment of lung infections, including pneumonia and bronchitis, and skin infections. Rib-X recently presented data from a successful Phase 2b study in which delafloxacin met or exceeded primary and secondary efficacy endpoints evaluated in comparison to Zyvox (linezolid; Pfizer), with and without aztreonam (Azactam; Elan Pharmaceuticals), and vancomycin, with and without aztreonam, including endpoints based on the new draft guidance from the FDA for ABSSSI.
Delafloxacin is being developed for use as a first-line antibiotic primarily in hospitals prior to the availability of a specific diagnosis. Delafloxacin has the potential to offer broad spectrum coverage as a monotherapy, including for methicillin-resistant Staphylococcus aureus (MRSA), with both intravenous (IV) and oral formulations. In addition to strong Gram-positive potency, delafloxacin has shown excellent in vitro activity against susceptible Gram-negative bacteria.
For more information call (203) 624-5606 or visit www.rib-x.com.