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Imara Presents Clinical and Preclinical Tovinontrine (IMR-687) Data at the American Society of Hematology (ASH) Annual Meeting 2021
12-month Phase 2a open-label extension clinical data in sickle cell disease shows patients on tovinontrine maintained reduced annualized rate of
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"12-month Phase 2a open-label extension clinical data in sickle cell disease shows patients on tovinontrine maintained reduced annualized rate of vaso-occlusive crises\nBOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced the presentation of 12-month data from its Phase 2a open-label extension (OLE) trial for tovinontrine (IMR-687) as a potential treatment for sickle cell disease (SCD) at the American Society of Hematology (ASH) Annual Meeting, held December 11-14, 2021. “These 12-month OLE data highlight the potential for tovinontrine to have longer term impact on VOC reductions. They also build upon previously-reported positive VOC results from the Phase 2a and OLE clinical trials,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “Reducing VOC rate is an established endpoint for regulatory approval and is becoming the primary endpoint of our ongoing Ardent Phase 2b clinical trial of tovinontrine in patients with sickle cell disease. We expect to report initial VOC data from the Ardent clinical trial in the first quarter of 2022 and continue to work with the FDA on a path towards registration.” SCD OLE Data Highlights:Imara is conducting a four-year OLE clinical trial, a safety and tolerability study comprised of patients who completed Imara’s Phase 2a clinical trial of tovinontrine in SCD. Subjects in the OLE clinical trial have received a once-daily dose of tovinontrine of 200 mg, and are in the process of being dose escalated to a once-daily dose of up to 400 mg. Of the 26 subjects enrolled, 21 were evaluable at month 12 as of the data cut-off. Tovinontrine was generally well-tolerated as a monotherapy as well as in combination with hydroxyurea. There were no clinically-significant changes in lab safety data, ECGs or vital signs, and no patients have discontinued the study due to adverse events. The median annualized VOC rate was reduced by 38% in subjects previously in the placebo group in the Phase 2a clinical trial (N=7), with median annualized VOC rates of 5.0 (Phase 2a) and 3.1 (OLE) per year; median duration of treatment was 6.4 months and 11.6 months, ...