Vasa Therapeutics has announced that the US 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. The company plans to immediately initiate a phase-I (c) clinical trial in the US for participants with Heart Failure with Preserved Ejection Fraction (HFpEF).

"After successful completion of our phase- I trial in healthy volunteers earlier this year, we are excited to initiate a phase-I (c) study of VS-041 in participants affected with HFpEF and elevated serum levels of endotrophin. This IND clearance marks a major milestone for Vasa, underscores the strength of our science and development strategy, and demonstrates exceptional execution. This next study will evaluate potential important effects of VS-041 on clinical and prognostic biomarkers of HFpEF, including endotrophin which is associated with excess morbidity and mortality," said Artur Plonowski, MD, Chief Executive Officer, Vasa Therapeutics.

The phase –I (c) study will assess the safety and tolerability of VS-041 in participants with HFpEF and elevated serum endotrophin. Data from this study could demonstrate target engagement and support dose selection for future clinical development.

"Endotrophin is recognised as a strong predictor of outcomes in HFpEF and may be an important contributor to its pathophysiology. A phase-I (c) study of VS-041 is the first step to evaluate prospectively the therapeutic impact of interrupting the generation of endotrophin," said Julio Chirinos, MD, PhD, Professor of Medicine–Cardiovascular Division, Perelman School of Medicine, University of Pennsylvania, and an expert in HFpEF and endotrophin, who also co-leads a Global Heart Failure biomarker consortium.