Mezzion Raises $40 Million to Advance a First-to-Market Treatment Option for Fontan Patients

Rare Daily Staff

Rare disease focused Korean biotech Mezzion Pharma has secured nearly $40 million to fund FUEL-2, its confirmatory phase 3 clinical trial of its experimental therapy for ventricle congenital heart disease, along with future commercialization and regulatory submissions in other countries including Europe.

The company made of its public share to BRV Capital Management, a global growth investment platform of BlueRun Ventures, a Silicon Valley-based institutional investment firm.

Mezzion is looking to commercialize Jurvigo (udenafil), a highly selective, unique and potent phosphodiesterase type 5 inhibitor, specifically for use in the estimated global 70,000 single ventricle congenital heart disease (SV-CHD) patients aged 12 and above who have undergone Fontan surgical palliation.

Fontan is a type of open-heart surgery usually performed in children between the ages of 18 and 36 months old who are born with issues like hypoplastic left heart syndrome, tricuspid atresia, and double outlet right ventricle.

The average life expectancy for a Fontan patient is 35-45 and apart from Jurvigo, there are currently no other pharmacotherapies in clinical development directed to the Fontan patient population. The primary aim of Jurvigo treatment in Fontan subject is to improve their exercise capacity, improve their ability to perform everyday physical activities with less effort, and potentially improve their life expectancy and quality of life. Another potential benefit associated with Jurvigo treatment may be the slowing of the progression of Fontan-associated liver disease in the Fontan subjects.

“We have secured the funds necessary for stable and aggressive progress of FUEL-2 and for submitting to regulatory authorities in other countries including Europe,” said Dong-Hyun Park, founder and CEO of Mezzion. “We submitted the FUEL-2 protocol to the FDA and partnered with a leading global CRO for what will be the largest clinical trial ever conducted in Fontan patients.”

Photo: Dong-Hyun Park, founder and CEO of Mezzion