Trigriluzole (BHV-4157) – for initial indication of Ataxias
Trigriluzole is a third-generation tripeptide prodrug that we are initially developing for the treatment of ataxias. Trigriluzole has the potential to be the first drug approved by the FDA for the treatment of ataxias, and we have chosen SCA as our lead indication. SCA is one of a group of rare genetic disorders that is characterized by slowly progressive incoordination of gait, speech and hand and eye movements. In general, a person with SCA retains full mental capacity but progressively loses physical control over voluntary muscles. No approved drug treatments for SCA are currently available.
We enrolled the first patient in our Phase 2/3 clinical trial in December 2016, and we expect to report topline results from this trial in early 2018. If the results of this trial are positive, we anticipate submitting a new drug application, or NDA, to the FDA in 2018.