Relief Therapeutics Holding Ltd (RLF.SW), a commercial-stage biopharmaceutical company, on Wednesday announced positive results from its pivotal bioequivalence clinical study evaluating RLF-OD032 for the treatment of phenylketonuria or PKU.
Following that, in the Swiss Market, the shares were trading 8.39% higher at 3.29 Swiss Francs.
Phenylketonuria, or PKU, is a genetic disorder caused by a deficiency of the enzyme needed to break down phenylalanine or Phe, leading to a toxic buildup of Phe from the consumption of protein or aspartame. With the lack of ability to metabolise Phe, present in many foods, PKU can cause severe neurological and developmental issues.
RLF-OD032 is a ready-to-use, portable and highly concentrated formulation of sapropterin dihydrochloride in liquid suspension for oral administration, designed to lower blood phenylalanine levels in adult and pediatric PKU patients.
By reducing the volume of medication required compared to current formulations, the improvement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments.
The pivotal study on RLF-OD032 achieved its primary pharmacokinetic endpoints, demonstrating that RLF-OD032 is bioequivalent to KUVAN Powder, the reference listed drug, as defined by the U.S. Food and Drug Administration.RLF-OD032 was well tolerated, with no serious adverse events reported.
The randomised, open-label, two-way crossover study compared the pharmacokinetics of RLF-OD032, administered without water, with those of the reference KUVAN Powder product, administered with water, as per its labelling under fed conditions.
Meanwhile, the results are based on a pre-database lock analysis or soft lock, where the raw data may still undergo final verification, cleaning, and auditing and are expected to be confirmed following final data verification.
"We are extremely pleased to have advanced RLF-OD032 from concept to clinical validation in just three years, demonstrating its bioequivalence and confirming its potential as the first ready-to-use liquid sapropterin formulation," said Giorgio Reiner, chief scientific officer of Relief Therapeutics.
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