Sanofi Multiple Sclerosis Drug Delays Disability Progression in Trial — Update

By David Sachs and Adria Calatayud

A Sanofi experimental drug for multiple sclerosis delayed disability progression in a late-stage trial, but failed to reduce episodes of new or worsening symptoms compared to an existing treatment in other clinical studies.

The French pharmaceutical company said Monday that results of the clinical trials for tolebrutinib, a drug candidate taken orally and being evaluated as a treatment of various forms of multiple sclerosis, will pave the way for discussions with regulators about potentially bringing the drug to market.

Sanofi's multiple sclerosis drug Aubagio lost patent protection in key markets last year and the company has been working on a new class of drugs to treat the neurodegenerative disease, which results in accumulation of irreversible disabilities over time. Sanofi sees disability accumulation as a significant unmet medical need for patients with the disease.

Tolebrutinib targets both a type of white blood cells and the central nervous system, aiming to address the underlying mechanisms of disability accumulation in multiple sclerosis patients, Sanofi said.

The company said the drug met the primary goal of a phase 3 trial by delaying disability progression in patients with nonrelapsing secondary progressive multiple sclerosis, a type of the disease in which patients have stopped experiencing confirmed relapses--episodes of new or worsening symptoms--but their disability continues to increase over time.

Tolebrutinib was compared to placebo in this trial, as there are currently no approved therapies for this type of multiple sclerosis, Sanofi said.

In European morning trade, shares in Sanofi climbed 2.8% to 104 euros, rising to levels last seen in April 2023.

In other late-stage trials evaluating tolebrutinib in people with relapsing multiple sclerosis, the drug failed to show significant improvement in reducing attack rates, missing the primary goal of the trials, Sanofi said. However, data from the trials pointed to a considerable delay in the appearance of confirmed disability worsening, supporting the results for disability progression found in the first trial, the company said.

Tolebrutinib was evaluated versus Aubagio in the relapsing multiple sclerosis trials, the company said. Patients with relapsing multiple sclerosis experience episodes of new or worsening symptoms followed by periods of partial or complete recovery and the U.S. National Multiple Sclerosis Society calls this the most common course of the disease.

The drug's miss in the relapsing multiple sclerosis trials might reduce its market potential in nonrelapsing secondary progressive multiple sclerosis, an indication for which other drugs are used off label, analysts at Bryan Garnier said in a note to clients.

The company will present results from the trials at a medical meeting on Sept. 20.

A fourth late-stage trial of tolebrutinib--focused on another type of multiple sclerosis--is under way, with results due to be released next year, Sanofi said.

Write to David Sachs at david.sachs@wsj.com and to Adria Calatayud at adria.calatayud@wsj.com

(END) Dow Jones Newswires

September 02, 2024 04:29 ET (08:29 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.