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Sanofi, Denali Drug Fails In ALS, Adding To RIPK1 Program Setbacks

Phase II Trial In Multiple Sclerosis Ongoing

 
• By Mandy Jackson

The companies have partnered on the development of RIPK1 inhibitors for multiple indications since 2018, but have yet to see success, having discontinued one of three drugs already.

Question mark made by white pills spilling out of brown glass bottle on pink background
It remains to be seen if RIPK1 inhibition will succeed in the clinic • Source: Shutterstock

Denali Therapeutics Inc. said on 16 February that SAR443820/DNL788, an oral brain-penetrant RIPK1 inhibitor co-developed with Sanofi, failed in the Phase II HIMALAYA clinical trial testing the drug in amyotrophic lateral sclerosis (ALS). The companies have moved three RIPK1 inhibitors into the clinic since entering into a collaboration in 2018 for which Sanofi paid Denali $125m up front, but they have yet to see success beyond Phase I for any of the drug candidates.

Key Takeaways

  • Denali said Sanofi’s Phase II trial of RIPK1 inhibitor SAR443820/DNL788 failed in a Phase II ALS trial, but a Phase II study in MS is ongoing.

    ...

South San Francisco-based Denali disclosed in a filing with the US Securities and Exchange Commission that, according to Sanofi, the HIMALAYA trial did not meet its primary endpoint of change...

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