Vitae Pharmaceuticals has 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.
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 ( CDC ), 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. ( Xagena )
Source: Vitae Pharmaceuticals, 2015