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Sanofi MS drug results set stage for extensive late-stage testing

With positive results from a mid-stage study in hand, Sanofi is pushing an experimental multiple sclerosis drug into an extensive late-stage research program comprised of four studies scheduled to begin in the middle of this year.More details from the Phase 2b study will be presented at an upcoming medical meeting, according to Sanofi. In the meantime, the French pharma disclosed Thursday that its drug significantly reduced the number of new brain lesions seen in patients with recurring MS while also being well tolerated, with safety findings in-line with previous research.Sanofi licensed the drug, which inhibits an enzyme known as BTK or Bruton’s tyrosine kinase, from Principia BioPharma in late 2017. While drugmakers have found success targeting BTK for cancer treatment, some have also been looking into its application in MS. Aside from Sanofi, Biogen and Merck KGaA have advanced BTK inhibitors into clinical trials of multiple sclerosis patients.

Known for diabetes care and, increasingly, investments in cancer and blood disorder drugs, Sanofi’s decision to move its BTK inhibitor into a large late-stage program suggests it still views MS as a priority target.

In 2019, the company recorded around $2.4 billion in net sales from its MS business, reflecting about a 2% increase from the year prior. Close to 90% of the sales came from Aubagio (teriflunomide), a drug approved in 2012 to treat the most common form of the disease, called relapsing MS. Sanofi’s other MS drug, Lemtrada (alemtuzumab), has been on the decline due to increased competition and a label change in Europe, according to the company.

The BTK drug may add to Sanofi’s portfolio, though that wouldn’t happen for some time.

Sanofi intends to initiate two Phase 3 trials in relapsing MS as well as two for rarer forms of the disease, known as primary and secondary progressive, in the middle of this year. The expectation is that a study testing its newer MS drug against Aubagio in relapsing MS will support the submission of an approval filing to U.S. regulators in the first half of 2024.

Later on, the company plans to submit its drug for primary and secondary progressive MS in the first half of 2025. Sanofi estimates there are, respectively, around 900,000, 120,000 and 172,000 patients diagnosed with relapsing, primary progressive and secondary progressive MS, and that the global market opportunity in MS exceeds 20 billion euros annually.

Though Sanofi has big aspirations for its drug, it may have to do some catching up. Merck KGaA began a Phase 3 study of its BTK inhibitor in August, with a primary completion date set for September 2023. In March 2018, the German biopharma released results from a Phase 2 trial that showed its drug led relapsing MS patients to have significantly fewer lesions compared to placebo.