Cempra (NASDAQ: CEMP) shares rose 38% following the company’s report of positive topline results from a phase 3 study of oral fusidic acid. The study, which took place in 716 patients with acute bacterial skin and skin structure infections, demonstrated that fusidic acid was well tolerated. Additionally, the study realized the primary endpoint, demonstrating non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response in the intent to treat patient population. The company plans to submit the full data from this study for presentation at an upcoming scientific forum. “We are excited that the results of this phase 3 study with fusidic acid confirm the results of our phase 2 study and are consistent with the more than 40 years of experience that the product has accumulated outside the United States,” chief medical officer David Oldach, M.D. stated in the news release.
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About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia. Cempra is currently seeking approval for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration and the European Medicines Agency. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeaeor chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Fusidic acid is Cempra’s second product candidate, which has completed an initial phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections. The company also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Additionally, the company is studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com
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