Mezzion Pharma raises $40M for treatment option for heart surgery patients

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Mezzion Pharma, a rare disease focused pharmaceutical company, has secured nearly $40 million to fund FUEL-2, its confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe.

Mezzion Pharma is looking to bring to market JURVIGO (udenafil), a highly selective, unique and potent phosphodiesterase type 5 (PDE-5) inhibitor, for specific 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.

The Fontan procedure

The Fontan procedure is a type of open-heart surgery. Children who need this surgery usually have it when they are between 18 and 36 months old. It is an operation for children born with issues like hypoplastic left heart syndrome (HLHS), tricuspid atresia, and double outlet right ventricle.

The average life expectancy for a Fontan patient is 35 to 45 and apart from JURVIGO, there are currently no other pharmacotherapies undertaking clinical development directed to the Fontan patient population. The primary aims of JURVIGO treatment in Fontan subjects are to improve their exercise capacity, boost 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.

Mezzion Pharma’s vision: supporting the Fontan patients

Founder and CEO, Dong-Hyun Park, said: “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, 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.

Explore other topics: Clinical trialFundingRare disease

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