RARITAN, NJ, September 6, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson today 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.
Janssen is proud of its decades-long commitment to advancing science in support of patients with pulmonary hypertension.
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.
Cautions Concerning Forward-Looking Statements
This media statement contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of macitentan 75 mg. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.