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IMARA Inc. (Nasdaq: IMRA) has received Orphan Drug Designation from the FDA for IMR-687, aimed at treating beta-thalassemia, following prior designation for sickle cell disease. This recognition emphasizes the need for innovative treatments for rare blood disorders. The company has initiated its Phase 2b clinical trial in the U.S., with plans for global regulatory submissions. IMR-687, a potent PDE9 inhibitor, increases cGMP levels which may help reactivate fetal hemoglobin, potentially improving patient outcomes.
Imara presented interim results from its Phase 2a trial of IMR-687 for sickle cell disease at the EHA Annual Congress. The data showed a statistically significant increase in fetal hemoglobin (HbF) and F-cells in high-dose groups after 24 weeks of treatment. IMR-687 was well tolerated both as monotherapy and with hydroxyurea. Following positive outcomes, a Phase 2b clinical trial will be initiated to explore higher doses over a year. The results suggest IMR-687 could be a promising oral therapy for sickle cell disease, with anticipated improvements in patient outcomes.
Imara Inc. (Nasdaq: IMRA) announced the presentation of interim data from its Phase 2a study of IMR-687 for sickle cell disease at the 25th Annual EHA Congress from June 11-21, 2020. The data will be presented by Dr. Biree Andemariam and will focus on IMR-687's efficacy in increasing F-Cells and fetal hemoglobin. The session will be accessible on-demand starting June 12, 2020, with top-line data expected in Q4 2020. IMR-687 is a potent PDE9 inhibitor aimed at improving blood flow and reducing symptoms in patients with sickle cell disease and beta-thalassemia.
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