Imara Inc. (NASDAQ: IMRA) has announced that the FDA has approved its investigational new drug application for tovinontrine (IMR-687) to start clinical development in heart failure with preserved ejection fraction (HFpEF) treatment. The company expects to start a Phase 2 study investigating tovinontrine in patients above 45 years with persistent HFpEF symptoms in Q2 2022.
Phase 2 to commence on Q2 2022
CEO Rahul Ballal, “We are excited to bring our deep expertise in clinical development and operations to patients suffering from HFpEF. 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.”
When contrasted to other PDE9 inhibitors, tovinontrine seems to be the best-in-class PDE9 inhibitor for investigation in the patient population, with in vitro results suggesting higher efficacy and specificity, as well as limited brain penetration.
Assistant Professor of Medicine at Vanderbilt University Medical Center’s Division of Cardiovascular Medicine, Deepak Gupta, stated, “The preclinical data strongly support moving tovinontrine into clinical testing for patients with HFpEF. 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.”
Primary endpoint will be NT-proBNP change
The Phase 2 HFpEF study by Imara will be a placebo-controlled, randomized trial involving about 170 individuals above 45 years who have enhanced PDE9 expression and persistent HFpEF symptoms. The trial participants will be dosed for a total of 16 weeks. The primary goal will be NT-proBNP change, with secondary endpoints including tolerability and safety and the quality of life assessments such theNew York Heart Association (NYHA) classification and Kansas City Cardiomyopathy Questionnaire (KCCQ). In addition, a clinical composite score, a six-minute walk test, and a heart structure and functioning evaluation are among the exploratory assessments.
Besides the company’s internal development team led by Toni Bransford, Imara’s VP of clinical development, the study will be also be overseen by the heart failure opinion leaders executive committee.
