eClinical Technology and Industy News

Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi

  • Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with multiple sclerosis
  • Denali to receive a milestone payment of $25 million from Sanofi for Phase 2 clinical trial initiation
  • Development of RIPK1 inhibitor program continues in a broad range of central nervous system and peripheral inflammatory conditions

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced that its partner Sanofi has commenced dosing in a Phase 2 study of SAR443820 (DNL788) in individuals with multiple sclerosis. SAR443820 is a central nervous system (CNS)-penetrant investigational small molecule inhibitor of RIPK1.

“Multiple sclerosis is a chronic and disabling, inflammation-mediated neurodegenerative disease with limited treatment options that target disease progression1,” said Nazem Atassi, M.D., Global Head of Early Neurology Development at Sanofi. “RIPK1 inhibition with SAR443820 is a novel therapeutic approach that may reduce inflammation and cell death associated with disease progression in multiple sclerosis. SAR443820 has demonstrated robust target engagement and CNS penetration at doses that were generally well tolerated in Phase 1 studies in healthy volunteers, and we are eager to learn more from this Phase 2 study of SAR443820 in multiple sclerosis as we strive to bring innovative therapies to people with unmet medical needs.”

“Following the initiation of the Phase 2 HIMALAYA study in ALS with SAR443820 last year by Sanofi, this Phase 2 study in multiple sclerosis marks another important milestone for our RIPK1 program,” said Carole Ho, M.D., Chief Medical Officer at Denali.

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