Accera attributes Phase III AD failure to bioavailability issue

Accera Inc. (Boulder, Colo.) said AC-1204 missed the primary endpoint in the Phase III NOURISH AD trial to treat mild to moderate Alzheimer's disease. Compared with placebo, the candidate failed to significantly improve AD Assessment Scale-cognitive subscale (ADAS-cog) score.

According to the company, a change in the formulation of AC-1204 between Phase II and Phase III trials “contributed to the lack of efficacy observed” in NOURISH AD by reducing exposure levels. Accera said it is “confident” that a new formulation will improve bioavailability and allow for a “more conclusive” efficacy test, and it intends to meet with FDA to discuss a path forward for the candidate...