Business
Imara Reports Full Year 2021 Financial Results and Business Highlights
Completed enrollment in Phase 2b sickle cell disease and beta-thalassemia trials with tovinontrine (IMR-687); expect to report both interim datasets in first
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"Completed enrollment in Phase 2b sickle cell disease and beta-thalassemia trials with tovinontrine (IMR-687); expect to report both interim datasets in first week of April 2022 Changed primary endpoint of Ardent Phase 2b trial in sickle cell disease to reductions in annualized rate of VOCs at written request of the FDA Added clinical indication for tovinontrine to include the treatment of HFpEF; anticipate first subject dosing in Phase 2 trial in second quarter of 2022 Expanded pipeline with addition of IMR-261, an oral, clinic-ready Nrf2 activator with potential indications in hemoglobin and iron overload disorders Company to host conference call and live webcast today at 8:30 AM ET BOSTON, March 15, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare hemoglobin disorders and other serious diseases, today reported financial results for the year ended December 31, 2021 and reviewed recent business highlights. “In 2021, we executed to plan by completing enrollment in our Phase 2b programs and keeping studies on track for upcoming interim readouts, despite the challenges of the COVID-19 pandemic,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “Furthermore, we added an important clinical indication in heart failure with preserved ejection fraction (HFpEF) for tovinontrine, and expanded our pipeline to include another oral, clinic-ready asset in IMR-261. Throughout the year we engaged the FDA on our sickle cell disease (SCD) program and in November 2021, received a written recommendation to change the primary endpoint for our Ardent Phase 2b clinical trial to annualized rate of vaso-occlusive crises (VOCs). We believe that this is a materially positive development since the reduction in annualized VOC rate is an important clinical outcome measure for patients and providers, as well as an established approval endpoint. We look forward to engaging the FDA again after our upcoming Ardent interim analysis on a registration path for tovinontrine.” Dr. Ballal continued, “At medical meetings in 2021, we presented data from our completed Phase 2a and ongoing Phase 2a open label extension trials of tovinontrine in adults with SCD that demonstrated its potential benefits wi...