FORT WASHINGTON, PA, USA I February 26, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced that its partner Boehringer Ingelheim has voluntarily placed BI 1181181 on a temporary clinical hold, and has notified regulatory agencies of its decision. BI 1181181 is an orally-active beta secretase (BACE) inhibitor being evaluated in Phase 1 clinical trials for the treatment and prevention of Alzheimer’s disease. This action was taken to further investigate skin reactions observed in some study participants during the multiple rising dose trial.

“Our partner is working diligently to evaluate and understand this observation,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We are confident that the analysis will result in a clear understanding of how to proceed with BI 1181181, and we remain committed to our partner and the BACE program. Depending on the outcome of the evaluation and Boehringer Ingelheim’s decision, we expect that either BI 1181181 or its structurally distinct, Phase 1-ready back up will be advanced, with the goal of delivering a medicine with disease-modifying benefits to patients suffering from Alzheimer’s disease.”

About Alzheimer’s Disease

Alzheimer’s disease is the most common type of dementia and is increasing in prevalence as the population ages. According to the Centers for Disease Control, Alzheimer’s disease was the 6th leading cause of death in the United States in 2013. In addition, as of 2013, an estimated 5.1 million Americans had Alzheimer’s disease, nearly all of whom are aged 65 or older, and approximately 200,000 individuals under age 65 have early onset of Alzheimer’s disease. The demographics highlight that the economic impact of Alzheimer’s disease is large and continuing to grow. According to the Alzheimer’s Foundation of America, in 2010, the cost of care for people over age 70 in the United States was between $157 billion and $210 billion.

About BI 1181181

BI 1181181 is Vitae Pharmaceuticals’ orally active BACE inhibitor that is being developed by Boehringer Ingelheim pursuant to a research collaboration and license agreement. Using its proprietary Contour(R) platform, Vitae discovered potent and highly selective BACE inhibitors that were orally active for lowering brain amyloid beta (Aβ) levels in animal models, and subsequently partnered with Boehringer Ingelheim to continue to progress these discoveries.

About Vitae Pharmaceuticals

Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing novel, small molecule drugs for diseases in which there are significant unmet medical needs. The company is developing a robust and growing portfolio of novel product candidates generated by Contour(R), its proprietary structure-based drug discovery platform.

SOURCE: Vitae Pharmaceuticals