Relief Therapeutics Reports Positive Study Results for Phenylketonuria Treatment

Relief Therapeutics Holding SA has announced positive results from their proof-of-concept clinical study for RLF-OD032, a new liquid formulation of sapropterin dihydrochloride intended for treating phenylketonuria (PKU). This four-way crossover pilot study assessed the pharmacokinetics of RLF-OD032 compared to the reference drug KUVAN®. The data indicated that RLF-OD032 under fed conditions, both with and without water, achieved similar bioequivalence levels as KUVAN®, meeting FDA standards.

Chief Scientific Officer Giorgio Reiner highlighted the meaningful data obtained for future development and regulatory strategies. Notably, RLF-OD032's administration without water and its low-volume dosage offer unique advantages for patient convenience. The company is preparing for a pivotal bioequivalence trial, aligning with the FDA's guidance, as part of the 505(b)(2) NDA process in the U.S.