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Imara Announces Results of Interim Analyses of Tovinontrine (IMR-687) Phase 2b Clinical Trials in Sickle Cell Disease and Beta-Thalassemia
Interim results in Ardent trial for sickle cell disease showed no significant difference in median annualized rate of vaso-occlusive crises in high-dose group
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"Interim results in Ardent trial for sickle cell disease showed no significant difference in median annualized rate of vaso-occlusive crises in high-dose group versus placebo in an intent-to-treat population Interim results in Forte trial for beta-thalassemia demonstrated no meaningful benefit in transfusion burden or improvement in most disease-related biomarkers Tovinontrine was generally well-tolerated across studies Both Phase 2b clinical trials and further development of tovinontrine in sickle cell and beta-thalassemia to be discontinued BOSTON, April 05, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA) today announced results from interim analyses of its Ardent Phase 2b clinical trial of tovinontrine (IMR-687) in patients with sickle cell disease (SCD) and Forte Phase 2b clinical trial of tovinontrine in patients with beta-thalassemia. Imara also announced that because of the data generated by these interim analyses, the company will discontinue the Ardent and Forte trials as well as the further development of tovinontrine in sickle cell disease and beta-thalassemia. “We are disappointed in the outcome of both of the interim analyses in our Phase 2b studies for sickle cell disease and beta-thalassemia, and particularly that the Ardent trial interim analysis did not replicate our previously observed positive vaso-occlusive crisis data,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We plan to discontinue both studies during the second quarter. As we do this, we remain deeply grateful to the patients, investigators and their teams for their participation in these trials and to the extended Imara team for their role and dedication in generating the comprehensive interim results.\" Dr. Ballal continued, \"Moving forward, we plan to consider our strategic options, including development of tovinontrine in heart failure with preserved ejection fraction (HFpEF) as well IMR-261 clinical development plans.” Ardent Phase 2b Sickle Cell Disease Interim Analysis:The interim analysis for the Ardent trial was conducted when all participants completed the week 24 assessment or terminated early. The intent-to-treat (ITT) population was used for the primary efficacy analysis, which is a comparison of the median annualized vaso-occlusive crisis (VOC) rate between the high dose tovinontrine group (n=47, once dail...