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Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)
eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; a Phase 1b study began in individuals with ALS in Q3
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; a Phase 1b study began in individuals with ALS in Q3 2021Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to SAR443820/DNL788, a RIPK1 inhibitor, for the treatment of ALS; Sanofi to initiate Phase 2 study in individuals with ALS in Q1 2022Denali to host webinar for analysts and investors today, October 6, at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (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 positive Phase 1 clinical results and regulatory progress for two investigational small molecule therapeutics in development for the treatment of amyotrophic lateral sclerosis (ALS) at the 2021 Annual Northeast ALS (NEALS) Meeting being held virtually, October 6-7. “Effective treatment options are a critical unmet medical need for people living with ALS,” said Carole Ho, M.D., Denali’s Chief Medical Officer. “DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively. We are pleased that the data generated preclinically and in Phase 1 studies support clinical investigation of both molecules as potential treatments for individuals with ALS.” “We’re very encouraged by the initial results of the Phase 1 study of SAR443820 for the treatment of ALS,” said Nazem Atassi, M.D., Sanofi’s Global Head of Early Neurodevelopment. “ALS is a devastating disease for patients and their families, with no available cure or effective treatment for slowing its progression. We look forward to launching the Phase 2 HIMALAYA trial in adults with ALS in early 2022 and to achieving our ultimate goal of helping people living with ALS.” Highlights from eIF2B activator DNL343 clinical and preclinical data presented at NEALS Denali presented positive results from a Phase 1 study in healthy volunteers (n=95) in which safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DNL343 were evaluated. The results demonstrated that DNL343 was generally well tolerated for up to 14 days of dos...