NASCAR is North Carolina’s best-known contribution to the fast track, but Chapel Hill clinical-stage pharmaceutical company Cempra is even giving NASCAR a run for its money.
Exactly one month ago the U.S. Food and Drug Administration gave its Qualified Infectious Disease Product (QIDP) “fast track” designation to Cempra’s solithromycin, an intravenous and tablet antibiotic for treating community-acquired bacterial pneumonia (CABP).
Now the FDA has done the same thing for Cempra’s second antibiotic product candidate, a fusidic acid compound named Taksta that is in stage-three clinical trials for the treatment of acute bacterial skin and skin structure infections.
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.
QIDP status qualifies the drug candidates for both fast track and priority review status, in addition to an additional five-year period of market exclusivity for the indication, if approved.
Taksta is also being developed for chronic oral treatment of refractory infections in bones and joints, including those that occur during hip and knee replacement surgery.
Both candidates target drug-resistant bacteria
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.
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.
Test results to be reported soon, then NDA in 2016
Intravenous solithromycin is currently in Phase 3 clinical development for the treatment of CABP. Cempra President and CEO Prabhavathi Fernandes, Ph.D., says her company expects to release top-line data from that study by the end of this year and submit the 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, a phase two trial in nonalcoholic steatohepatitis, and a phase one-b trial in pediatric patients.
Solithromycin is licensed to Cempra’s strategic commercial partner, Toyama Chemical Co., a subsidiary of FUJIFILM Holdings, for certain exclusive rights in Japan.