A phase 3 trial of Johnson & Johnson’s multiple sclerosis prospect ponesimod has met its primary endpoint. The readout sets J&J up to file for approval later this year, boosting its prospects of getting a return on its $30 billion takeover of Actelion.
S1P1 modulator ponesimod was one of two late-phase programs J&J picked up in the acquisition. J&J scrapped a phase 3 trial of the other late-phase asset, a treatment for Clostridium difficile-associated diarrhea, in 2018, leaving relapsing multiple sclerosis candidate ponesimod as its last chance to make a profit on the experimental programs included in the Actelion deal.
The phase 3 data move J&J a step closer to commercial sales of ponesimod, but key questions remain unanswered. In a release to disclose the news, J&J said ponesimod beat Sanofi’s Aubagio against the primary endpoint and most secondary goals.
That suggests ponesimod is better than Sanofi’s blockbuster at controlling the annualized relapse rate and fatigue-related symptoms, respectively the primary endpoint and a key secondary objective. But with J&J yet to share data from the trial, it is unclear at this stage how big an effect ponesimod had on patients.
Such details will matter, because ponesimod will face stiffer competition than Aubagio if it comes to market. Aubagio was a rising star when Actelion began the phase 3 trial in 2015, but it now faces competition from Roche’s Ocrevus. Indirect analyses suggest Ocrevus is better than Aubagio at reducing relapses.
J&J is running another phase 3 trial to assess the performance of ponesimod versus placebo in active relapsing multiple sclerosis patients who are taking Biogen’s Tecfidera. That trial is still recruiting and has a primary completion date of 2020. J&J plans to file for approval before then, with submissions on both sides of the Atlantic scheduled for before the end of 2019.
The progress of ponesimod is a boost for Idorsia Pharmaceuticals, a spinout from Actelion that will receive 8% of the net sales of the drug.