Positive pivotal bioequivalence study of Relief’s RLF-OD032

Swiss biopharma Relief Therapeutics (SIX: RLF) today announced positive results from its pivotal bioequivalence clinical study evaluating RLF-OD032, Relief’s innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU).

The pivotal study achieved its primary pharmacokinetic endpoints, demonstrating that RLF-OD032 is bioequivalent to Kuvan Powder, the reference listed drug, as defined by the US Food and Drug Administration (FDA) and marketed by US biotech BioMarin Pharmaceutical (Nasdaq: BMRN).

The randomized, open-label, two-way crossover study compared the pharmacokinetics of RLF-OD032 (administered without water) and the reference product (administered with water, as per its labeling) under fed conditions. RLF-OD032 was well tolerated, with no serious adverse events reported. These results are based on a pre-database lock analysis (soft lock) and are expected to be confirmed following final data verification.