Cempra wavering over FDA hepatotoxicity concerns on solithromycin

3 November 2016

Antibiotics specialist Cempra (Nasdaq:CEMP) is facing a nervous wait after a US Food and Drug Administration (FDA) briefing document raised concerns over solithromycin, a potential treatment for community acquired bacterial pneumonia (CABP) which is one of the company’s two lead product candidates.

The FDA’s Antimicrobial Drugs Advisory Committee will meet on Friday to discuss the concerns and other risks and benefits of the solithromycin oral capsule and injection, based on the US firm's data on the semi-synthetic antibacterial drug of the macrolide class/ketolide subclass, including the results of Phase III trials.

News of the FDA reviewer’s concerns sent Cempra’s share price plummeting by more than 60%, though it has picked up by nearly 9% in Thursday's early trading to $7.92. The key safety point surrounds the drug's potential to raise liver enzyme levels.

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