Sanofi Ends Phase II Trials for MS Drug Oditrasertib After Failures
Sanofi has halted its Phase II study of oditrasertib, a RIPK1 inhibitor intended for multiple sclerosis (MS), after the drug failed to meet its primary and key secondary endpoints[1][2]. The study, which included over 170 patients, aimed to assess the drug's effect on serum neurofilament light chain levels, a biomarker for neurodegenerative diseases[1]. Despite its intended mechanism of reducing brain inflammation and preventing neuronal death, the trial did not demonstrate significant changes compared to placebo[2]. This decision follows previous failures, including an abandoned Phase II trial for amyotrophic lateral sclerosis earlier in the year[1][2].
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What were the specific primary and secondary endpoints that oditrasertib failed to meet in the Phase II trial?
How does the failure of oditrasertib impact Sanofi's collaboration strategy with Denali Therapeutics moving forward?
What alternative therapeutic approaches is Sanofi exploring for multiple sclerosis following the discontinuation of oditrasertib?
How does oditrasertib's failure compare to other recent treatments for neurodegenerative diseases like multiple sclerosis?
What were the key biomarkers used in the trial to measure oditrasertib's efficacy, and why did the drug fail to influence these markers?