Dr. Rahul Rathod to Lead Global Phase 3 FUEL-2 Trial for Mezzion Pharmaceuticals

Mezzion Pharmaceuticals, a firm dedicated to treating rare diseases, has initiated the pivotal phase 3 FUEL-2 clinical trial focusing on individuals who have undergone the Fontan procedure. The company has appointed Dr. Rahul Rathod, a distinguished pediatric cardiologist with over two decades of experience at Boston Children's Hospital, as the Global Principal Investigator for this trial. Dr. Rathod holds esteemed positions at the hospital and is an Associate Professor at Harvard Medical School. He is renowned for his expertise in single ventricle heart disease and Fontan circulation, with a significant publication record and leadership in the Fontan Outcomes Registry Using CMR Examinations (FORCE), which is the largest global database for Fontan patients.

In his role for the FUEL-2 trial, Dr. Rathod will be responsible for guiding the clinical trial process, ensuring protocol adherence, and managing operations across all participating sites. His responsibilities also include leading data analysis and aiding in the communication of findings to the FDA. The trial is designed to explore the potential of udenafil, a PDE5 inhibitor, to improve the quality of life for Fontan patients by potentially increasing blood flow to the lungs and thus possibly enhancing blood oxygen levels.

Dr. John Hariadi, who recently joined Mezzion Pharmaceuticals from Johnson & Johnson, praised Dr. Rathod's appointment, highlighting his unmatched expertise in Fontan physiology. The FUEL-2 trial, sponsored by Mezzion Pharmaceuticals, is expected to be the most extensive clinical trial for the Fontan patient population, with plans to enroll 438 participants globally. Currently, 22 U.S. sites are in the process of enrolling participants.

Udenafil's potential to relax blood vessels and possibly increase lung blood flow is being closely examined in this trial, which could translate to reduced fatigue during exercise and daily activities for the participants. The study aims to provide substantial medical advancements for a patient group that faces complex health challenges and has significant unmet needs.

Mezzion Pharmaceuticals, headquartered in Korea with an administrative office in New Jersey, is an innovative pharmaceutical company committed to developing new treatments for rare pediatric diseases. The company is publicly traded on the Korean stock exchange.