IMARA Inc. (IMRA) Q3 2020 Earnings Call

Investor webinar replay

Replay transcript excerpt

enrollment response, and it's an increase of HBF of 3% or greater from baseline to week 24 versus placebo. And the trial is powered for statistical significance for this endpoint. Patients will continue on treatment through 52 weeks to provide data for planned secondary and additional endpoints, including the evaluation of IMR687 versus placebo on VOCs, HPF-associated biomarkers, indices of red cell hemolysis. white blood cell adhesion, quality of life measures, and NT-PRO-BNP. The 4-T trial is designed to analyze the line of placebo-cold patients with beta-alcemia. The trial will evaluate the safety and tolerability of IMR-687 in approximately 60 transfusion-dependent patients and approximately 60 non-transfusion-dependent patients. Additionally, for transfusion-dependent patients, we plan to evaluate the effect of IMR67 versus placebo on transition burden and the change in iron load as a result of transfusion during the trial and in comparison recorded rates in the 12 weeks prior to initiation. The FORTE trial will also examine additional exploratory efficacy endpoints as well as safety and PK endpoints. Like our ARDENT study, We plan to continue utilizing weight-based dosing with potential doses as high as 400 mg. Safety and tolerability will be assessed after 24 weeks of dosing. As a reminder, we plan to report formal interim analysis for phase 2B trials when 33 and 30 patients respectively have completed 24 weeks of treatment. Due to COVID-19 enrollment delays, we are adjusting our expected time to report interim data on these trials from our previously estimated timeline of the first half of 2021 to the second half of 2021. I can assure you that our team has worked diligently internally as well as with our CRO and clinical site to minimize delays as much as pos...