Mezzion Pharmaceuticals, a rare disease company, has appointed Dr. Rahul Rathod as the Global Principal Investigator for its pivotal phase 3 clinical trial, the Fontan Udenafil Exercise Longitudinal Assessment Trial-2 (FUEL-2). 

Dr. Rathod, a distinguished pediatric cardiology specialist with over two decades of expertise at Boston Children's Hospital, brings extensive experience to this crucial role.

As the Associate Chair of Cardiology and Director of the Single Ventricle Program at Boston Children's Hospital, along with being an Associate Professor of Pediatrics at Harvard Medical School, Dr. Rathod is renowned internationally for his contributions to the field of single ventricle heart disease and Fontan circulation. With more than 80 peer-reviewed publications and as the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE), Dr. Rathod's leadership ensures robust oversight of the FUEL-2 trial.

In his role as Global Principal Investigator, Dr. Rathod will lead the clinical trial, overseeing protocol implementation, conduct, and operations across all study sites. He will also spearhead the study's analysis and contribute to reporting the results to the Food and Drug Administration (FDA).

"FUEL-2 represents a pivotal moment in Fontan research, offering promising advancements for our patients," stated Dr. Rathod. "This landmark study explores the potential of udenafil to enhance the quality of life for Fontan patients, addressing significant medical complexities and unmet needs."

Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion expressed confidence in Dr. Rathod's appointment, citing his unparalleled expertise in Fontan physiology. "Mezzion is proud to partner with Dr. Rathod as we advance this pivotal clinical trial," he remarked.

FUEL-2, sponsored by Mezzion Pharmaceuticals, aims to investigate the clinical efficacy and safety of udenafil in teenagers aged 12-18 who have undergone the Fontan procedure. With plans to enroll 438 patients globally, the trial is poised to be the world's largest Fontan clinical trial. Currently, 22 sites in the U.S. are enrolling or will begin enrolling shortly.

Udenafil, a selective phosphodiesterase type 5 (PDE5) inhibitor, holds the potential to enhance blood flow to the lungs, thereby increasing blood oxygen levels and reducing fatigue during physical activity. As FUEL-2 progresses, it offers hope for redefining treatment strategies for Fontan patients worldwide.