Vasa Therapeutics, a clinical-stage biotechnology company developing novel therapies for cardiovascular and metabolic aging, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for VS-041, a narrow-spectrum small molecule inhibitor of matrix metalloproteinases. With this clearance, the company plans to immediately initiate a Phase 1c clinical trial in the United States to evaluate VS-041 in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).

“Following the successful completion of our Phase 1 trial in healthy volunteers earlier this year, we are thrilled to advance VS-041 into a Phase 1c study in participants affected by HFpEF with elevated serum endotrophin,” said Artur Plonowski, MD, Chief Executive Officer of Vasa Therapeutics. “This IND clearance marks a major milestone for Vasa, underscores the strength of our science and clinical strategy, and reflects our team’s exceptional execution. The upcoming study will assess key biomarkers of HFpEF, including endotrophin, which is closely associated with adverse outcomes in this patient population.”

The Phase 1c study will evaluate the safety, tolerability, and target engagement of VS-041 in participants with HFpEF and elevated serum endotrophin. The results are expected to inform dose selection and further development in subsequent clinical trials.

“Endotrophin is a strong predictor of clinical outcomes in HFpEF and is thought to play a critical role in its pathophysiology,” said Julio Chirinos, MD, PhD, Professor of Medicine in the Cardiovascular Division at the Perelman School of Medicine at the University of Pennsylvania and a global expert in HFpEF and endotrophin biology. “This Phase 1c study represents an important first step in prospectively evaluating the therapeutic potential of targeting endotrophin generation in HFpEF.”