Cempra, a clinical-stage pharmaceutical company in Chapel Hill, has received fast track designation from the U.S. Food and Drug Administration for solithromycin, an antibiotic for treating community-acquired bacterial pneumonia (CABP).
“We look forward to working with the FDA to streamline the development and review of this promising drug,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
Fast track designation is reserved for new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track drugs typically qualify for priority review, and their developers are allowed to submit completed sections of their New Drug Application (NDA) on a rolling basis.
Cempra is developing solithromycin in intravenous and tablet forms. Intravenous solithromycin is currently in phase three clinical development for the treatment of CABP. Cempra said in a news release it expects to release top-line data from the study by the end of this year and submit an NDA in 2016.
Additional clinical studies with solithromycin include a phase three trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a phase two trial in chronic obstructive pulmonary disease (COPD), a phase two trial in nonalcoholic steatohepatitis (NASH), and a phase one-b trial in pediatric patients.
Solithromycin is licensed to Cempra’s strategic commercial partner, Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corp., for certain exclusive rights in Japan.
Cempra’s second product candidate, a fusidic acid compound named Taksta, is being developed for chronic oral treatment of refractory infections in bones and joints, including those that occur during hip and knee replacement surgery. Fusidic acid has a long history of safety and efficacy outside the United States, and Cempra has exclusive rights to the supply of the compound for the U.S. market.
Both solithromycin and Taksta seek to treat drug-resistant bacterial infections. They work by inhibiting the synthesis of proteins required for bacterial cells to grow and proliferate.
Cempra was founded in 2006. The North Carolina Biotechnology Center supported the company in 2014 with a $3,000 Industrial Internship award to the company, bringing a business intern into the company to help provide economic research data on the costs of hospital care for treating CABP.
(C) N.C. Biotechnology Center