IMRA - Imara gets positive DMC opinion for higher dose arm in mid-stage sickle cell disease trial
Imara (IMRA) announces 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 have recommended opening of the higher dose IMR-687 treatment arm in each of these studies following review of available safety and tolerability data.The additional study arms were pre-specified in the two protocols and enrollment is proceeding at the IMR-687 higher dose (once daily dose of 300 mg or 400 mg based on patient weight), lower dose (once daily dose of 200 mg or 300 mg based on patient weight), or placebo.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.The company expects to begin dose escalation to the higher dose under an amended protocol by mid-2021.
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Imara gets positive DMC opinion for higher dose arm in mid-stage sickle cell disease trial