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Imara Announces Completion of Patient Enrollment in Ardent Phase 2b Clinical Trial of IMR-687 (tovinontrine) for Sickle Cell Disease
Interim analysis expected in fourth quarter of 2021 and primary endpoint readout now expected in first quarter of 2022 BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE)
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"Interim analysis expected in fourth quarter of 2021 and primary endpoint readout now expected in first quarter of 2022\nBOSTON, Aug. 05, 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 and other serious diseases, today announced that the company has completed patient enrollment in the Ardent Phase 2b clinical trial of IMR-687, a potent small molecule inhibitor of PDE9, for the treatment of sickle cell disease (SCD). Imara also announced that the United States Adopted Names (USAN) Council adopted “tovinontrine” (pronounced toe” vi non’ treen) as the generic name for IMR-687. “We are pleased to achieve this important milestone for IMR-687,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “Furthermore, we are excited to have enrolled subjects from across the world, including in Africa, making this a truly global effort. We look forward to reporting interim data for the Ardent trial in the fourth quarter of this year and can now refine guidance and expect to report data from the primary analysis in the first quarter of 2022.” The Ardent Phase 2b clinical trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of IMR-687 administered once daily in approximately 99 adult patients with sickle cell disease. Patients are randomized to 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. The trial is being conducted at approximately 50 sites in 13 different countries. About IMR-687 (tovinontrine)IMR-687 (tovinontrine) is a highly selective and potent small molecule inhibitor of PDE9. PDE9 uniquely degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology. Lower levels of cGMP are often found in people with sickle cell disease and beta-thalassemia and are associated with impaired blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide-mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which are associated with reactivation of fetal hemoglobin, o...