Bristol Myers Squibb said Wednesday it will enroll more patients in a key Phase 3 trial studying its drug Cobenfy in psychosis associated with Alzheimer’s disease, after the company found “irregularities due to clinical trial execution” at a small number of study sites.
After consulting with the Food and Drug Administration, Bristol had an independent group conduct an interim analysis for efficacy and safety. Based on the analysis, the study’s data monitoring committee recommended continuing the study by enrolling more patients to reach the original target population, the company said.
Bristol shares were up some 3% in premarket trading Wednesday morning.
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