On 22 December, Vivoryon Therapeutics N.V., a clinical stage company focused on developing innovative small molecule-based medicines, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for its lead product candidate varoglutamstat for Alzheimer’s disease (AD). Fast Track designation 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.
Varoglutamstat, also named PQ912, is an investigational oral small molecule medicine for the potential treatment of early AD. Varoglutamstat is currently being investigated in two Phase II clinical trials with early and mild AD: the European VIVIAD study and the recently initiated US VIVA-MIND study. The VIVIAD clinical trial remains on track for an interim safety readout in mid-2022 with anticipated final data in the second half of 2023.
