FDA Grants Fast Track Status to VS-041, a Novel MMP Inhibitor for HFpEF

Vasa Therapeutics has received FDA Fast Track designation for VS-041, its lead investigational small-molecule inhibitor of MMP-2 and MMP-9 being developed for heart failure with preserved ejection fraction (HFpEF). Fast Track is intended for therapies addressing serious conditions with unmet medical needs and enables more frequent FDA interaction, rolling NDA submissions, and potential eligibility for priority review.

Why the Designation Matters?

FDA’s decision highlights the potential for VS-041 to:

• Address a major unmet need in HFpEF
• Target the underlying fibroinflammatory biology of the disease
• Support a precision-medicine approach using serum endotrophin, an emerging biomarker linked to worse outcomes

Current Clinical Development

VS-041 has shown:

• Selective inhibition of MMP-2 and MMP-9
• Reduction of fibroinflammation in preclinical HFpEF models
• Favorable safety and tolerability in a Phase 1 study in healthy participants

A Phase 1c proof-of-mechanism study (NCT07219511) is now underway in HFpEF patients with elevated serum endotrophin. This is the first clinical trial specifically targeting this high-risk subgroup.

FDA cleared the IND for this study on October 10, 2025.

Executive Commentary

Dr. Noreen Henig (CMO) noted that Fast Track status reinforces the potential of VS-041’s mechanism and supports the possibility of establishing a biomarker-driven diagnostic and therapeutic paradigm in HFpEF.

CEO Artur Plonowski stated that the designation marks an important milestone and said the company is on track to have two clinical-stage assets in 2026.

About VS-041

• Oral small molecule developed internally by Vasa
• Designed for diseases driven by fibroinflammation, including HFpEF, hypertrophic cardiomyopathy, and chronic kidney disease
• Co-funded by the European Regional Development Fund and Polish National Centre for Research and Development (POIR.01.01.01-00-1210/10-01)

About HFpEF

HFpEF is a progressive form of heart failure marked by:

• Stiffening and fibroinflammation of the heart muscle
• Impaired relaxation despite preserved systolic function

Epidemiology:

• ~3 million affected in the U.S.
• ~10 million globally

Current therapies improve symptoms but do not modify the underlying disease or offer durable benefit after discontinuation.

About Vasa Therapeutics

Vasa is a clinical-stage company focused on cardiovascular and muscle aging biology. Its pipeline includes four assets directed toward:

• Heart failure
• Sarcopenia
• Peripheral arterial disease
• Rare neuromuscular diseases
• Life-threatening arrhythmias

A long-acting apelin analog, VS-214, is planned to enter first-in-human testing in 2026.

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