Janssen Announces Phase 3 Success for Ponesimod in Relapsing Multiple Sclerosis, Plans Regulatory Submission in 2019

Today, Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, announced that ponesimod, an investigational therapy for the treatment of relapsing multiple sclerosis (MS), met the primary endpoint and most secondary endpoints in its Phase 3 clinical trial.

Multiple sclerosis is a chronic autoimmune inflammatory disease that affects the central nervous system (CNS). It impacts the lives of 2.3 million people worldwide, with women being more affected than men. Typical symptoms in patients include demyelination and nerve damage, leading to impaired neurological function and severe disability. The main subtype of MS is relapsing-remitting multiple sclerosis (RRMS), which accounts for 85% of MS cases.

Ponesimod is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator. This class of drugs reduces the number of circulating lymphocytes by inhibiting S1P receptor activity, thereby sequestering lymphocytes within lymph nodes. Consequently, fewer inflammatory cells can enter the central nervous system (CNS) to damage myelin. Myelin is the protective sheath surrounding nerves and is damaged in patients with multiple sclerosis (MS). S1P receptors have become an important therapeutic target for MS; Novartis’ Mayzent and Celgene’s ozanimod both target this receptor family.

▲Molecular structure of Ponesimod (Image source: Anypodetos [CC0])

OPTIMUM: A Randomized, Double-Blind, Active-Controlled, Phase 3 Superiority Clinical Trial Designed to Compare the Efficacy, Safety, and Tolerability of Ponesimod Versus the Approved Therapy Teriflunomide in Patients With Relapsing Multiple Sclerosis. This study enrolled 1,133 patients and had a treatment duration of up to 108 weeks, with the primary endpoint being the annualized relapse rate (ARR) through the end of the study.

The trial results demonstrated that ponesimod met the primary endpoint compared with teriflunomide. Detailed data from this study will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Janssen Pharmaceuticals, Inc. stated that data from the OPTIMUM study will form the basis for regulatory submissions to the U.S. FDA and the European EMA, with the company expecting to file these applications later this year.

References:

[1] Janssen reports positive top-line Phase 3 results for ponesimod in adults with relapsing multiple sclerosis. Retrieved July 25, 2019, from https://www.prnewswire.com/news-releases/janssen-reports-positive-top-line-phase-3-results-for-ponesimod-in-adults-with-relapsing-multiple-sclerosis-300891338.html

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