NEW HAVEN, Conn., Sept. 14 Rib-X Pharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel drugs for the treatment of multi-antibiotic resistant infections, today announced that it intends to enter into a Clinical Trials Agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. The purpose of this agreement is to advance the clinical development of an oral formulation of Rib-X's novel fluoroquinolone delafloxacin, in the treatment of Neisseria gonorrhoeae.
N. gonorrhoeae, a gram-negative bacteria, is the cause of the sexually transmitted disease gonorrhea which affects more than 700,000 people in the United States annually. Currently, N. gonorrhoeae has become resistant to a number of antibiotics, including penicillin and other quinolones. Delafloxacin is a next-generation fluoroquinolone that has been shown to be very active against gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA) and a broad range of gram-negatives. In addition to work under this agreement, Rib-X is preparing to progress delafloxacin to Phase 3 clinical trials for multiple indications.
This agreement with the NIAID will further support the broad clinical potential for our lead compound, delafloxacin, which has already demonstrated potent activity against a variety of resistant bacteria and has successfully completed three Phase 2 trials," said Susan Froshauer, PhD, President and CEO of Rib-X Pharmaceuticals. "In recent years, gonococcal infections have become increasingly resistant to available antibiotic treatments and we look forward to collaborating with the team at NIAID in the coming months to evaluate possible alternative therapeutic options for such infections."
Delafloxacin, a novel, broad spectrum, next-generation fluoroquinolone, has demonstrated better activity than other quinolones against Gram-positive bacteria, including isolates of MRSA that are quinolone-resistant. Recently, Rib-X has announced positive results from a Phase 2 trial utilizing the IV formulation of delafloxacin in complicated skin and skin structure infections (cSSSI). Delafloxacin successfully completed two previous Phase 2 trials with the oral formulation. In microbiological tests of large numbers of contemporary clinical isolates, the compound has been shown to be at least 32-fold more potent than levofloxacin, ciprofloxacin, gatifloxacin and moxifloxacin against quinolone-resistant MRSA (MIC90 of = 0.5 ug/ml for delafloxacin compared to > 16 ug/ml for all other quinolones) and twice as potent as daptomycin against MRSA. Additionally, delafloxacin was shown to more potent than ciprofloxacin against N. gonorrhoeae (MIC90 of = 0.06 ug/ml for delafloxacin compared to > 16 ug/ml for ciprofloxacin). Delafloxacin has also been shown to be more potent than existing quinolones against a range of Gram-positive, anaerobic and Gram-negative organisms. Rib-X is currently developing both IV and oral formulations of delafloxacin for use in surgical prophylaxis and other therapeutic arenas within the over $9.9 billion hospital antibiotic market.
About Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc. is a product-driven small molecule drug discovery and development company focused on the structure-based design of new classes of antibiotics. The Company's underlying drug discovery engine capitalizes on its proprietary high-resolution crystal structure of the ribosome, which performs an essential role in protein synthesis. Many known, commercially valuable antibiotics exert their effects by binding to the bacterial ribosome. The Company's integrated research strategy, which combines state-of-the-art, proprietary computational analysis, X-ray crystallography, medicinal chemistry, microbiology and biochemistry, allows it to rapidly synthesize new agents designed to avoid typical antibiotic resistance mechanisms. Rib-X's iterative intelligent engine has yielded several distinctive new antibiotics that can be used for the treatment of either community- or hospital-acquired infections. In addition to delafloxacin, Rib-X has completed two Phase 2 trials with radezolid (RX-1741), an oxazolidinone that was discovered at Rib-X, as an oral/IV agent for treatment of serious Gram-positive infections. The Rx-04 discovery program is developing novel classes of antibiotics active against multi-drug resistant Gram-negative bacteria and the Rx-02 discovery program is focused on developing an IV/oral macrolide active against MRSA, multidrug-resistant Streptococcus pneumoniae and S. pyogenes.
For more information on the Rib-X mission and the pipeline, please visit the Company website at www.rib-x.com.
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SOURCE Rib-X Pharmaceuticals, Inc.