Rib-X Pharmaceuticals Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA for Radezolid
today announced that the Food and Drug Administration (FDA) designated radezolid as a Qualified Infectious Disease Product (QIDP) for oral and intravenous (IV) use for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). This is the second drug candidate in Rib-X’s pipeline to receive QIDP designation. that the FDA designated delafloxacin as a QIDP for ABSSSI and CABP.
Radezolid is a next-generation oxazolidinone designed to be a potent antibiotic with intravenous (IV) and oral formulations and a safety profile permitting long-term treatment of resistant infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Radezolid has completed two Phase 2 clinical trials with an oral formulation in uncomplicated skin and skin structure infections (uSSSI) and in community acquired bacterial pneumonia (CABP). A Phase 1 study with an IV formulation was recently completed in healthy subjects. Rib-X recently from a positive Phase 1 intravenous (IV) dosing study conducted in healthy subjects and an long-term safety study versus linezolid.
Mark Leuchtenberger, Chief Executive Officer of Rib-X said, “The need for antibiotics that safely treat a broader spectrum of infections, not to mention those which have shown resistance to linezolid, is growing and radezolid has thus far succeeded in addressing a diverse set of challenges in ABSSSI and CABP. GAIN provides important development incentives to aid companies developing novel antibiotic drugs and we are pleased to take advantage of the benefits provided under this program for now a second promising candidate in our pipeline.”
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.
Through a rational drug design process involving approximately 700 prototype compounds, Rib-X developed radezolid to have structural advantages that make it a candidate for use as a treatment for serious infections, such as ABSSSI and severe CABP, and long-term treatment of underserved serious infections, such as osteomyelitis and prosthetic and joint infections. The demonstrated broad- spectrum of coverage, potency and potential long-term safety profile of radezolid could give it the potential to become the antibiotic of choice for multiple resistant bacterial infections, and for treatment in populations, such as the elderly and children, that might be vulnerable to myelosuppression caused by other oxazolidinone treatments.
is a biopharmaceutical company developing new antibiotics to provide superior coverage, safety and convenience for the treatment of serious and life-threatening infections. The Company's proprietary drug discovery platform provides an atomic-level, three-dimensional understanding of interactions between drug candidates and their bacterial targets and enables design of antibiotics with enhanced characteristics. Rib-X has two antibiotic candidates in clinical development. Delafloxacin is an enhanced spectrum IV/oral antibiotic intended for use as first-line monotherapy primarily in hospitals and recently completed a Phase 2b clinical trial for the treatment of acute bacterial skin and skin structure infections. Radezolid is a next-generation IV/oral oxazolidinone designed to be a potent antibiotic with a safety profile permitting long-term treatment of resistant infections. The Company's pipeline also includes its preclinical RX-04 program, partnered with Sanofi, S.A., and other discovery stage anti-infective programs. .