Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients

Mezzion Pharma, a rare disease-focused pharmaceutical company, announced that it has secured nearly $40M USD to fund FUEL-2, their confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion is looking to bring to market JURVIGO® (udenafil), a highly selective, unique and potent phosphodiesterase type 5 inhibitor (“PDE-5 inhibitor”), for specific use in the estimated global 70K single ventricle congenital heart disease (“SV-CHD”) patients with ages of twelve and above who have undergone Fontan surgical palliation.

The average life expectancy for a Fontan patient is 35-45 and apart from JURVIGO®, there are currently no other pharmacotherapies undertaking 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.

Founder and CEO, Mr. Dong-Hyun Park, shared, “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. 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. In addition, we are expanding on 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 the Fontan patients, others will be inspired to do the same.”

The investment is a paid-in capital increase from BRV Capital Management (“BRV Capital”), a global growth investment platform of BlueRun Ventures, a Silicon Valley-based institutional investment firm known for its early lead investment in PayPal and Waze, the core technology behind Google Maps. Within their healthcare segment, BRV Capital invests in promising biotech companies that can dominate the global market based on differentiated products. BRV has made successful investments/exit into ST Pharm and Arvelle Therapeutics.

Mr. Yoon Kwan, CIO of BRV Capital, stated, “BRV Capital participated in the Cardiology Conference by Children’s Hospital of Philadelphia (CHOP) in Puerto Rico at the end of February of this year and met many doctors and heart disease related professionals in person as part of its diligence effort. And also, we’ve been thoroughly reviewing Mezzion’s FUEL-1 data and the U.S. FDA’s response letters and comments carefully for a long time. As a result, the possibility of new drug approval based on the FUEL-2 Protocol was evaluated very high, so the head office decided to invest in Mezzion.”

Mr. Kwan continued with, “The future market value was estimated considering attainable drug price after commercialization. BRV, as an institutional investor that focuses not on short-term profits, but on differentiated technology-based investments that can substantially grow, we would like to provide support from the new drug approval of udenafil to the success of global commercialization with strong partnership. We also subscribe to Mezzion’s corporate philosophy of helping all the patients around the World who are suffering from congenital diseases to open-up a new life.”