Boehringer Ingelheim has temporarily placed on hold a Phase I clinical trial assessing its experimental BACE inhibitor BI 1181181 in Alzheimer’s disease, to further investigate potential side effects.
Its partner Vitae Pharmaceuticals explained that the decision was undertaken after skin reactions were observed in some study participants during the multiple rising dose trial.
Richard Gregg, Vitae’s chief scientific officer, said Boehringer is “working diligently to evaluate and understand this observation," and stressed the firm remains “confident that the analysis will result in a clear understanding of how to proceed with BI 1181181”.
Depending on the outcome and BI’s decision, “we expect that either BI 1181181 or its structurally distinct, Phase I-ready back up will be advanced, with the goal of delivering a medicine with disease-modifying benefits to patients suffering from Alzheimer's disease,” Gregg said.
BI 1181181 was discovered and developed under an alliance between Boehringer and Vitae that was established in 2009.