FDA grants fast track designation for Huntington’s disease treatment

Sage Therapeutics Inc. announced it has received FDA fast track designation for SAGE-718 as a potential treatment for Huntington’s disease.

“Cognitive decline is often one of the earliest signs of [Huntington’s disease (HD)], and this decline, in addition to other symptoms, results in a devastating impact on independence, general functioning and quality of life,” Jim Doherty, PhD, chief research officer at Sage Therapeutics, said in a press release from the company. “We believe that improving cognitive function is one of the core paths to maintaining quality of life in HD and remains an area of significant unmet medical need.”

According to Doherty, studies have shown an association between SAGE-718 and improved cognitive performance, particularly in the executive functioning domain. The treatment is an N-methyl-D-aspartate (NMDA) receptor positive allosteric modulator in development as a potential oral therapy for cognitive disorders linked to NMDA receptor dysfunction, such as HD, Parkinson’s disease and Alzheimer’s disease. Ongoing studies seek to assess whether SAGE-718 can improve cognitive symptoms for these disorders.

Sage Therapeutics intends to initiate a placebo-controlled phase 2 trial with SAGE-718 for early-to-moderate HD in late 2021, the company said in the release.

“The FDA fast track designation is an important milestone in the development of SAGE-718, as it provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review of SAGE-718 for the treatment of HD,” Doherty said.