American pharmaceutical company Cempra (Nasdaq: CEMP) has announced positive news from a Phase III study into oral fusidic acid for acute bacterial skin and skin structure infections (ABSSSI).
Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority against oral linezolid for early clinical response. The company's share price rose by a quarter following the news.
Cases of ABSSSI, which may be associated with an underlying disease such as diabetes, lead to more than five million hospitalizations in the USA and Europe each year.
Cempra will now meet with the US Food and Drug Administration to chart a regulatory course for the drug, which has been used in Europe for decades. The full results from the study will be submitted at an upcoming scientific forum.
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