Vivoryon and Simcere announce CDE approval of Chinese clinical trial application

MUNICH: Vivoryon Therapeutics N.V. and Simcere Pharmaceutical Group announced that China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat (SIM0408, PQ912), a medicine in development for the treatment of Alzheimer’s disease (AD) developed in Greater China by Simcere.

 “We are proud to have obtained CDE approval of our Clinical Trial Application of varoglutamstat which represents our strong commitment in the battle against Alzheimer’s disease,” said Dr. Renhong Tang, Executive Vice President of Simcere. “We will push forward the Phase 1 clinical study of varoglutamstat in China with all our efforts, and prepare to join the active global Phase 2 efforts.”

“We are delighted with Simcere’s rapid progress towards bringing new treatment options to the millions of patients suffering from Alzheimer’s disease in China,” said Dr. Michael Schaeffer, Chief Business Officer of Vivoryon.

“Varoglutamstat has already demonstrated encouraging clinical results in earlier studies, and we look forward to building on our experience from the completed and ongoing studies in the EU and U.S. to support our partner during this significant phase in development.”

Varoglutamstat is a differentiated oral small-molecule inhibitor with a unique mode of action designed to address several key mechanisms underlying AD pathology, including Abeta pathology, tau pathology, neuroinflammation and synaptic impairment. Varoglutamstat is currently in Phase 2 clinical development in Europe (VIVIAD study) and the U.S. (VIVA-MIND study).

On June 29, 2021, Simcere and Vivoryon entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China and comprises Vivoryon’s clinical lead product candidate varoglutamstat (SIM0408, PQ912) as well as Vivoryon’s preclinical monoclonal N3pE-antibody PBD-C06.


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