Independent Data Monitoring Committees endorse opening higher dose IMR-687 treatment arms in ongoing Ardent and Forte Phase 2b clinical trials after review of safety and tolerability data at lower doses
Safety Review Committee in Phase 2a open label extension trial supports daily dose increase to align with higher dose arms of Phase 2b clinical trials
BOSTON, March 17, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced that separate independent data monitoring committees (DMCs) for the Ardent and Forte Phase 2b clinical trials of IMR-687 for sickle cell disease and beta-thalassemia, respectively, have recommended opening of the higher dose IMR-687 treatment arm in each of these studies following review of available safety and tolerability data. These additional arms were pre-specified in the two protocols and enrollment is proceeding in each study at the IMR-687 higher dose (once daily dose of 300 mg or 400 mg based on patient weight), IMR-687 lower dose (once daily dose of 200 mg or 300 mg based on patient weight), or placebo.
“We are pleased that the DMCs’ review of safety data has resulted in opening of the higher dose arms in the Forte Phase 2b clinical trial in patients with beta-thalassemia in January and more recently in the Ardent Phase 2b clinical trial in patients with sickle cell disease in March,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We designed each of these trials to allow for the additional higher dose arm of IMR-687 and expect to report preliminary data from the higher dose arms as part of our planned data readouts in the second half of 2021. Dosing in our recently completed Phase 2a clinical trial in sickle cell disease started as low as 50 mg per day and escalated sequentially to 100 mg or 200 mg per day over 16-24 weeks. Dosing in the Phase 2b clinical trials is substantially higher, both at the starting dose and through the treatment period, which is 36 weeks for the Forte trial and 52 weeks for the Ardent trial.”
Similar to the Phase 2b clinical trials, a separate safety review committee reviewed the available safety and tolerability data from patients in Imara’s ongoing Phase 2a open label extension (OLE) clinical trial of IMR-687 in patients with sickle cell disease and recommended increasing the daily dose from 200mg to either 300 mg or 400 mg, based on patient weight. This dose level is identical to the higher dose arms of the Phase 2b clinical trials and it is anticipated that patients will begin dose escalation to the higher dose under an amended protocol by mid-2021.
Additional information about the Ardent, Forte and OLE clinical trials can be found at www.clinicaltrials.gov.