Denali’s Sanofi-partnered RIPK1 inhibitorRIPK1 inhibitor fails ALS study

16 Feb 2024
firstwordpharma.com
Phase 2Acquisition
Denali Therapeutics reported in a securities filing Friday that its experimental amyotrophic lateral sclerosis (ALS) treatment missed the primary endpoint in a Phase II study run by partner Sanofi. Shares in the biotech slipped 7% on the news, which isn’t the first setback the collaborators have faced.
The RIPK1 inhibitorRIPK1 inhibitor – known as either DNL788 or SAR443820 – missed the primary endpoint of change in ALS Functional Rating Scale-Revised (ALSFRS-R) in the 305-person Phase II HIMALAYA study. Denali said the results will not impact the Phase II K2 study in multiple sclerosis, for which Sanofi recently finished enrolling 174 patients.
Sanofi and Denali partnered in 2018 to develop a pair of RIPK1 inhibitorsRIPK1 inhibitors against a range of neurological and systemic inflammatory diseases. The French pharma spent $125 million upfront on the deal, which is worth up to $1 billion in biobucks – but DNL788 wasn’t one of the original compounds.
In 2020, Denali swapped out DNL747 for DNL788 after non-human primate studies of the former limited the firm’s confidence to conduct safe dose-escalation studies. DNL788, a backup compound at the time, was prioritised because early clinical and preclinical data suggested it had "superior drug properties." For more, see ViewPoints: Denali switches gears in neuroinflammation.
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