Mezzion Pharma, a pharmaceutical company focused on rare diseases, has secured nearly $40 million to fund FUEL-2, its confirmed phase 3 clinical trials, along with future commercialization and regulatory filings in other countries including Europe.
Mezzion Pharma wants to market JURVIGO (udenafil), a highly selective, unique and potent phosphodiesterase type 5 (PDE-5) inhibitor, for specific use in approximately 70,000 global single ventricular congenital heart disease (SV-CHD) patients aged 12 years and over who had undergone Fontan palliative surgery.
The Fontan procedure is a type of open heart surgery. Children who need this surgery usually have it between the ages of 18 and 36 months. This is an operation for children born with problems such as hypoplastic left heart syndrome (HLHS), tricuspid atresia, and double outflow tract right ventricle.
The median life expectancy for Fontan patients is 35 to 45 years and apart from JURVIGO, there is currently no other pharmacotherapy underway for clinical development aimed at the Fontan patient population. The main goal of JURVIGO treatment of Fontan subjects is to increase their exercise capacity, increase their ability to carry out daily physical activities with minimal effort, and potentially increase their life expectancy and quality of life.
Another potential benefit associated with JURVIGO treatment might slow the progression of Fontan-related liver disease in Fontan subjects.
Mezzion Pharma’s vision: supporting Fontan patients
Founder and CEO, Dong-Hyun Park, said: “We have secured the necessary funds for the steady and aggressive advancement of FUEL-2 and to deliver it to regulatory authorities in other countries including Europe. We submitted the FUEL-2 protocol to the FDA and partnered with a leading global CRO for the largest clinical trial ever conducted in Fontan patients. In addition, we are expanding global partnerships with hospital systems, advocacy groups, provider networks, and industry leaders dedicated to improving outcomes for those with SV-CHD. Our hope is that by continuing to invest in and support Fontan patients, others will be inspired to do the same.”
The investment represents an increase in paid-in capital from BRV Capital Management, global growth investment platform BlueRun Ventures, a Silicon Valley-based institutional investment firm known for seed investments in PayPal and Waze, the core technology behind Google Maps. Within their healthcare segment, BRV Capital invests in promising biotechnology companies that can dominate the global market based on differentiated products.