Phase 2 trial on potential new drug for MS pulled

Pharmaceutical company Sanofi has decided to halt a Phase 2 clinical trial for oditrasertib, an investigational RIPK1 inhibitor therapy, in people living with relapsing and progressive multiple sclerosis (MS) after the treatment did not meet its intended goals.

The trial, which involved 174 participants primarily from Europe, had patients randomly assigned to either oditrasertib tablets or a placebo for 48 weeks, followed by an open-label extension where all participants would receive the therapy for an additional 48 weeks.

Launched early last year, the trial was unable to demonstrate that oditrasertib significantly reduced levels of neurofilament light chain (NfL), a marker of nerve damage. It also failed to meet other secondary outcomes, according to a report filed by Denali Therapeutics, Sanofi’s development partner.

The Phase 2 K2 study (NCT05630547), sponsored by Sanofi, aimed to assess the effects of oditrasertib on blood NfL levels in adults aged 18-60 who had either relapsing-remitting, secondary progressive, or primary progressive MS.