Vivoryon Therapeutics Receives FDA Fast Track Designation for Varoglutamstat in Early Alzheimer's Disease
Vivoryon Therapeutics N.V., a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for varoglutamstat (PQ912), an investigational oral small molecule medicine for the potential treatment of early Alzheimer's disease (AD).
Varoglutamstat is Vivoryon's lead product candidate and is designed to block formation of N3pE amyloid, a particularly neurotoxic variant of the Abeta peptide, by inhibiting glutaminyl cyclase (QPCT) and its isoenzyme (QPCTL). Varoglutamstat is currently being investigated in two Phase 2 clinical trials in patients living with early and mild AD: the European Phase 2b VIVIAD study and the recently initiated Phase 2a/b VIVA-MIND study in the U.S.
"Having been granted Fast Track designation for varoglutamstat in early AD is extremely encouraging and we value the opportunity to interact closely with the FDA as we progress varoglutamstat through clinical development in the U.S.," said Dr. Ulrich Dauer, CEO of Vivoryon. "We fully recognize the dire need for safe and widely available therapies to treat this devastating disease and remain dedicated to contributing to the global effort of improving the lives of the millions of patients, families and caregivers affected."
Fast Track is a process designed to facilitate the development, and expedite the review of drugs with the potential to treat serious conditions and fill an unmet medical need, aiming to bring important new drugs to the patient earlier. With Fast Track designation, the development of varoglutamstat can benefit from more frequent engagement with the FDA to discuss varoglutamstat's development plan and ensure collection of the appropriate data needed to successfully advance varoglutamstat through clinical development. A drug that receives Fast Track designation is also potentially eligible for Accelerated Approval and Priority Review, if relevant criteria are met.
December 22, 2021
