On 28 February, Vivoryon Therapeutics N.V., a clinical stage company focused on developing innovative small molecule-based medicines, announced the China’s Center for Drug Evaluation (CDE) approval of its Clinical Trial Application of varoglutamstat for Alzheimer’s disease (AD) in China. Varoglutamstat, also named PQ912, is an investigational oral small molecule medicine for the 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 US VIVA-MIND study. Vivoryon Therapeutics has received Fast Track designation for varoglutamstat in early AD by the US Food and Drug Administration (FDA) in December 2021. The designation enables Vivoryon to have more frequent interactions with the FDA during the development process. The main goal of the fast-track program is to accelerate the review of therapies that potentially improve care for serious diseases.
