Johnson & Johnson to halt hypertension drug Macitentan study
The study was deemed "futile" and failed to improve exercise capacity in a broad population including inoperable patients compared to a placebo, J&J said.
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced its decision to stop the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) due to futility. The decision to stop the trial was made in accordance with a recommendation by the study’s independent data monitoring committee following a pre-planned interim analysis. No new safety signals were observed.
The interim results of MACiTEPH do not impact any of the Company's commercialized pulmonary hypertension medicines. Additionally, the pivotal Phase 3 UNISUS study, which aims to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with pulmonary arterial hypertension, is currently continuing as planned.
MACiTEPH is a prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study in patients with CTEPH. It evaluates the efficacy and safety of macitentan 75 mg compared to placebo on exercise capacity, the primary efficacy endpoint, in a broad population including inoperable patients and those who underwent mechanical treatment, including pulmonary endarterectomy or balloon pulmonary angioplasty.
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