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Imara Announces FDA Clearance of Investigational New Drug Application (IND) for Tovinontrine (IMR-687) for Heart Failure with Preserved Ejection Fraction (HFpEF)
Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims to select HFpEF patients with enriched PDE9 expressionfor targeted approach to a heterogeneous disease Study initiation planned for second quarter of 2022 BOSTON, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare hemoglobin disorders and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for tovinontrine (IMR-687) to commence clinical development for the treatment of heart failure with preserved ejection fraction (HFpEF). Imara plans to initiate a Phase 2 trial in the second quarter of 2022 to evaluate tovinontrine in patients 45 years of age or older with persistent HFpEF symptoms. “We are excited to bring our deep expertise in clinical development and operations to patients suffering from HFpEF,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We expect to initiate the Phase 2 trial in the second quarter of 2022, with a design that focuses on identifying HFpEF patients with high PDE9 expression, creating a targeted approach in this prevalent disease. With tovinontrine we believe we have the best-in-class PDE9 inhibitor for evaluation in this patient population, with in vitro data demonstrating superior potency and selectivity, as well as minimal brain penetration when compared to other PDE9 inhibitors.” “The preclinical data strongly support moving tovinontrine into clinical testing for patients with HFpEF,” said Deepak Gupta, M.D., M.S.C.I, Assistant Professor of Medicine at Vanderbilt University Medical Center’s Division of Cardiovascular Medicine. “Study inclusion criteria, such as increased left ventricular hypertrophy and elevated N-terminal pro b-type natriuretic peptide, or NT-proBNP levels, enrich for patients with higher PDE9 expression, making this a selective proof-of-concept approach.” Imara’s Phase 2 HFpEF trial will be a randomized, placebo-controlled study of approximately 170 patients 45 years of age or older with enriched PDE9 expression and persistent symptoms of HFpEF. Trial subjects...