UK’s MHRA Authorizes Vasa to Initiate First-in-Human Clinical Trial of VS-041

4 September 2024

Prague, Czech Republic – September 4, 2024 – i&i Bio is relaying the following news from its portfolio partner Vasa Therapeutics (“Vasa”). Vasa, a clinical-stage biopharmaceutical company focused on developing innovative therapies for cardiovascular and metabolic aging, yesterday announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) to initiate a Phase 1 first-in-human clinical trial. This trial will evaluate the safety, tolerability, and pharmacokinetics of Vasa’s investigational drug, VS-041, in healthy adult participants.

VS-041, an oral compound discovered and developed by Vasa, is aimed at treating heart failure with preserved ejection fraction (HFpEF). Preclinical models have shown that VS-041 significantly reduces cardiac fibrosis and improves diastolic heart function.

Vasa Therapeutics is a privately held company dedicated to addressing the pathophysiologies of cardiovascular and metabolic aging. Beyond VS-041, Vasa has developed a pioneering platform for long-acting apelin, intended for combination treatment with incretins in obesity, particularly for patients at risk of skeletal muscle loss or cardiovascular disease. As a monotherapy, long-acting apelin agonists may also benefit conditions such as muscle atrophy, heart failure, chronic kidney disease, and peripheral artery disease. Vasa’s preclinical pipeline includes a best-in-class inhibitor of CamKIId for heart failure and life-threatening arrhythmias.

In July 2024, Vasa Therapeutics secured investment from i&i Bio and Orphinic Scientific SA, a Polish early-stage investor and life science development platform, which has been a long-standing supporter of Vasa.

i&i Biotech Fund (i&i Bio)

i&i Bio is a Luxembourg-based venture capital firm investing in innovative European life sciences companies specializing in drug discoveries, medical devices, diagnostics, and digital health. The fund, created through a collaboration between the biotech incubator i&i Prague and the European Investment Fund (EIF), manages over €53 million and aims to invest in approximately 20 early-stage companies. Led by a team with extensive experience in private equity, healthcare, and venture capital, i&i Bio supports entrepreneurs in achieving global success. The fund’s main sponsor, i&i Prague, plays a crucial role in advancing transformative Central European technology companies.

About the European Investment Fund (EIF)

The Fund is supported by an investment from the EIF, with the support of:

lnnovFin Equity, with the financial backing of the European Union under Horizon 2020 Financial Instruments and the European Fund for Strategic Investments (EFSI) set up under the Investment Plan for Europe. The purpose of EFSI is to help support financing and implementing productive investments in the European Union and to ensure increased access to financing; and
the Pan-European Guarantee Fund (EGF), implemented by the EIF with the financial support of the Participating Member States. The objective of EGF is to respond to the economic impact of the COVID-19 pandemic by ensuring that companies in the Participating Member States have sufficient short-term liquidity available to weather the crisis and are able to continue their growth and development in the medium to long-term.