The FDA signed off Imara Inc's (NASDAQ:IMRA) investigational new drug (IND) application for tovinontrine (IMR-687) in heart failure with preserved ejection fraction (HFpEF).
- The Company plans to initiate a Phase 2 trial in Q2 of 2022 to evaluate tovinontrine in patients 45 years of age or older with persistent HFpEF symptoms.
- The Phase 2 HFpEF trial will be a randomized, placebo-controlled study of approximately 170 patients. Trial subjects will be dosed for 16 weeks.
- The primary endpoint will be a change in NT-proBNP, with secondary endpoints that include safety and tolerability and quality of life measures.
- Exploratory measures include a clinical composite score, a 6-minute walk test, and cardiac structure & function evaluation.
- Related: Imara Changes Primary Endpoint In Mid-Stage Sickle Cell Disease Trial.
- Tovinontrine is a highly selective and potent small-molecule inhibitor of phosphodiesterase-9 (PDE9).
- PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production.
- Price Action: IMRA shares are down 5.10% at $1.49 during the market session on the last check Tuesday.
