Vasa Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for VS-041, a novel small-molecule inhibitor targeting matrix metalloproteinases, for the treatment of heart failure with preserved ejection fraction (HFpEF). According to the company, the clearance allows it to immediately launch a Phase 1c clinical trial in the United States in participants with HFpEF and elevated serum endotrophin levels.
The upcoming Phase 1c study will assess the safety, tolerability and target engagement of VS-041 in this patient population, with data expected to inform dose selection for future development. The company claims the therapy has shown promising effects in preclinical models, including reductions in cardiac fibrosis, improved diastolic function, and inhibition of endotrophin release from human cardiac fibroblasts.
Vasa notes that VS-041 was co-funded by the European Regional Development Fund and the Polish National Centre for Research and Development. The therapy is being developed not only for HFpEF but also for other chronic diseases characterized by fibroinflammation, such as hypertrophic cardiomyopathy and chronic kidney disease, according to the company’s disclosures.
HFpEF is a progressive form of heart failure marked by stiffening and fibroinflammation of the heart muscle, and current therapies generally manage symptoms without modifying underlying disease architecture. Vasa sees VS-041 as a potential first-in-class candidate that could alter disease progression in selected HFpEF patients with elevated endotrophin.
