Janssen’s Ponesimod OPTIMUM trial in MS meets primary endpoint

Ponesimod OPTIMUM trial results :  Johnson & Johnson’s Janssen Pharmaceutical said that the phase 3 OPTIMUM clinical trial evaluating ponesimod yielded positive results compared to Aubagio (teriflunomide) in adults having relapsing multiple sclerosis (MS).

The OPTIMUM clinical trial, which enrolled 1,133 participants, assessed the efficacy and safety of the selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for a treatment duration of 108 weeks.

The late-stage multiple sclerosis clinical trial met its primary and most of the secondary endpoints.

The primary endpoint of the Ponesimod OPTIMUM trial was annualized relapse rate (ARR) up to the end of the clinical trial. A major secondary endpoint was variation from baseline to week 108 in fatigue-related symptoms.

Janssen’s Ponesimod OPTIMUM trial in MS meets primary endpoint and most secondary endpoints. Photo courtesy of Stuart Miles/Freedigitalphotos.net.

In addition to that, the phase 3  multiple sclerosis clinical trial assessed other secondary endpoints such as cumulative number of combined unique active lesions (CUALs) using magnetic resonance imaging (MRI), time to first 24-week CDA from baseline to end of the study, and time to first 12-week confirmed disability accumulation (CDA) .

The safety profile observed for the investigational drug in the Ponesimod OPTIMUM trial was on par with its previous clinical trials, and other S1P receptor modulators’ known safety profile.

According to Janssen Pharmaceutical, ponesimod is a class of drugs that is thought to functionally block S1P activity and lower the number of circulating lymphocytes by trapping them in the lymph nodes. As a result, there are fewer inflammatory cells available to cross into the central nervous system (CNS) where they can cause damage to myelin, which is a protective sheath that insulates nerve cells and is damaged in multiple sclerosis patients.

Data from the Ponesimod OPTIMUM trial will be used by Janssen Pharmaceutical as basis of its submissions to the US Food and Drug Administration and European Medicines Agency to seek approval of the investigational drug as a treatment for relapsing types of multiple sclerosis, which are expected for later this year.