J&J Terminates Phase III Study of Blockbuster Opsumit in Pulmonary Hypertension
07 Sep 2023
Phase 3AcquisitionDrug Approval
Pictured: J&J office in Spain/iStock, BrasilNut1
J&J subsidiary Janssen announced on Wednesday that it was terminating the Phase III MACiTEPH trial of its cardiology asset Opsumit (macitentan) in chronic thromboembolic pulmonary hypertension.
The decision to drop the study is in line with the recommendation of an independent data monitoring committee, which found during a pre-planned interim analysis that MACiTEPH met the criteria for futility. The trial was evaluating a 75-mg dose of Opsumit.
J&J was quick to point out in Wednesday’s announcement that there were no new safety signals observed, while noting that MACiTEPH’s interim results and discontinuation will “not impact any of the company’s commercialized pulmonary hypertension medicines.”
Opsumit, an endothelin receptor antagonist, is approved for reducing the risks of disease progression and hospitalization in patients with pulmonary arterial hypertension. The drug picked up this indication in October 2013, when it was still owned by Swiss biopharma Actelion. J&J acquired Actelion for $30 billion in January 2017. Patent protections for Opsumit are set to expire in 2025, according to J&J’s patent portfolio.
By blocking endothelin receptors, Opsumit disrupts their downstream effects including fibrosis, hypertrophy, vasoconstriction and inflammation.
Opsumit comes with a boxed warning for embryo-fetal toxicity. Its label recommends against treatment in pregnant women. For those who could get pregnant, doctors are advised to rule out pregnancy before administration.
J&J is continuing its R&D work for Opsumit, seeking to push the drug into new indications or expand its label with new treatment schedules. The MACiTEPH study was part of this effort. With 230 patients enrolled, the randomized, double-blinded trial compared a 75-mg dose of Opsumit with placebo, assessing its efficacy primarily through exercise capacity.
The company is also currently running the Phase III UNISUS study, which is evaluating the higher 75-mg dose of Opsumit in pulmonary arterial hypertension, as compared with its currently approved 10-mg formulation. MACiTEPH’s discontinuation will not affect UNISUS, J&J said in its announcement on Wednesday.
J&J is also proposing the combination regimen of Opsumit with tadalafil fixed-dose combination as a treatment for pulmonary arterial hypertension, for which it submitted the New Drug Application in May 2023.
Since joining J&J’s portfolio in 2017, Opsumit has reached blockbuster status, netting the company more than $1.78 billion in 2022. While this represents a slight 2% dip compared with its nearly $1.82 billion in revenue in 2021, Opsumit remains the top-selling asset in J&J’s pulmonary hypertension business.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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