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Chapel Hill, N.C. — Chapel Hill clinical-stage pharmaceutical company Cempra got a much-needed boost when it lifted the lid on the data for its Phase 3 clinical trial examining the effectiveness of its lead drug candidate, Taksta.
The news sent Cempra shares soaring.
Shares traded at $4.22, up 34 percent, at midday, according to North Carolina Business News Wire.
Voila! Taksta, Cempra’s fusidic acid compound, is proving to be both safe and effective in the treatment of acute bacterial skin and skin structure infections.
Actually, fusidic acid has a long history of safety and efficacy outside the United States, so it’s not a complete surprise that it’s looking good in the U.S. Food and Drug Administration review process. What’s especially upbeat, though, is that Cempra has exclusive rights to the supply of the compound for the U.S. market.
In 2015 the FDA gave Taksta a Qualified Infectious Disease Product (QIDP) “fast track” designation. QIDP status qualified the drug candidate for both fast track and priority review status, in addition to an additional five-year period of market exclusivity for the indication, if approved.
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 on a rolling basis.
Taksta is also being developed for chronic oral treatment of refractory (stubborn or otherwise unmanageable) infections in bones and joints, including those that occur during hip and knee replacement surgery.
Taksta is designed to treat drug-resistant bacterial infections by inhibiting the synthesis of proteins required for bacterial cells to grow and proliferate.
Cempra, founded in 2006, has grown into a publicly traded company employing as many as 80 people. The North Carolina Biotechnology Center supported Cempra in 2014 with a $3,000 Industrial Internship award.
The company suffered a major setback at the end of 2016. The FDA ruled that it would need additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies before it would give market approval for solithromycin, Cempra’s lead product candidate at the time. The company hoped to bring that drug to the clinic to treat community-acquired bacterial pneumonia. Solithromycin had also received fast-track approval before it went off the tracks.
(C) N.C. Biotechnology Center
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