ARTICLE | Clinical News

JNJ-Q2 misses ABSSSI endpoint

November 11, 2010 1:57 AM UTC

Furiex Pharmaceuticals Inc. (NASDAQ:FURX) said oral twice-daily JNJ-Q2 missed the primary endpoint of non-inferiority to twice-daily Zyvox linezolid in a Phase II trial to treat acute bacterial skin and skin structure infections (ABSSSI). Non-inferiority was measured by the proportion of patients achieving an early clinical response as measured by a composite analysis of skin lesion size and stabilization temperature within 36-84 hours after starting treatment (74.7% vs. 79.5%). However, an analysis of early clinical response using an FDA-defined endpoint measuring both cessation of skin lesion spread or reduction in lesion size and absence of fever within 48-72 hours of starting treatment showed that JNJ-Q2 was non-inferior to Zyvox on the endpoint (62.7% vs. 57.7%). The double-blind, U.S. trial enrolled 161 patients. ...