Sanofi tells Denali that SAR443820/DNL788 missed Phase II primary endpoint

19 February 2024

US biotech Denali Therapeutics (Nasdaq: DNLI) saw its shares drop more than 8% to $16.66, after it revealed a setback for a partnered drug candidate in a stock exchange filing.

On Friday, Denali said that it has been informed by its strategic partner, French pharma major Sanofi (Euronext: SAN), that the Phase II HIMALAYA study evaluating SAR443820/DNL788 in participants with amyotrophic lateral sclerosis (ALS) did not meet the primary endpoint of change in ALS Functional Rating Scale-Revised (ALSFRS-R).

Sanofi intends to present the detailed efficacy and safety results of the ALS Phase II HIMALAYA study at a future scientific forum. SAR443820/DNL788 is an investigational oral brain-penetrant RIPK1 inhibitor being co-developed by Sanofi and Denali. However, Sanofi will continue to conduct the K2 Phase II study of SAR443820/DNL788 in participants with multiple sclerosis.

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