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Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in ALS by Sanofi
Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with amyotrophic lateral sclerosis (ALS)Denali to receive
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with amyotrophic lateral sclerosis (ALS)Denali to receive a milestone payment of $40 million from Sanofi for Phase 2 clinical trial initiationDevelopment of RIPK1 inhibitor program continues in a broad range of CNS and peripheral inflammatory indications SOUTH SAN FRANCISCO, Calif., May 02, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that its partner Sanofi has commenced dosing in a Phase 2 study, named HIMALAYA, of SAR443820 (DNL788) in individuals with amyotrophic lateral sclerosis (ALS). SAR443820 is a central nervous system (CNS)-penetrant small molecule inhibitor of RIPK1. “ALS is a devastating neurodegenerative disease for which effective treatment options are a critical unmet medical need,” said Nazem Atassi, M.D., Sanofi’s Global Head of Early Neuro Development. “We are very encouraged by the results from the Phase 1 trial of SAR443820 in healthy volunteers in which robust target engagement was demonstrated at doses that were generally well tolerated. Based on these results, we are excited to start the HIMALAYA Phase 2 ALS study and look forward to working with Denali and the ALS community to advance the development of this novel investigational therapy.” “The initiation of this Phase 2 study marks a significant milestone in the SAR443820 development program and our RIPK1 inhibitor collaboration with Sanofi,” said Denali’s Chief Medical Officer, Carole Ho, M.D. “We are excited about the progression of Denali’s portfolio in ALS with this milestone. Denali is committed to collaborating with the ALS community as we work toward a unified goal of developing potentially life-saving therapeutics for people living with ALS.” About SAR443820 and Sanofi RIPK1 Inhibitor Collaboration Denali and Sanofi entered into a broad partnership in October 2018 for the global development and commercialization of peripherally restricted and CNS-penetrant RIPK1 inhibitors. RIPK1 is a critical signaling protein in the tumor necrosis factor (TNF) receptor pathway and is a regulator of inflammation and cell death. Increased RIPK1 activity in the brain dr...