Relief Therapeutics Holding SA / Key word(s): Study results Relief Therapeutics Reports New Study Results for RLF-OD032 and Files Provisional Patents New Study Results Indicate Superior Absorption of RLF-OD032 in Fasted State Compared to KUVAN®, Potentially Enabling Flexible Dosing Options GENEVA (OCT. 25, 2024) - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced new positive clinical study results for RLF-OD032 and the filing of provisional patent applications in the United States. The patents, based on these new findings, cover additional claims for Relief's investigational drug RLF-OD032, a highly concentrated, novel liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU). The patent filings follow the recently announced completion of a pilot, proof-of-concept, four-way crossover study that evaluated the pharmacokinetic profile of RLF-OD032 and its absorption in both fasted and fed conditions. The Company previously reported that RLF-OD032, when administered in fed conditions without water, achieved peak and total exposure of sapropterin dihydrochloride similar to those achieved by the reference product (KUVAN® Powder) administered with water. Today, Relief announced additional positive and unexpected results from the study that form the basis of these new patent applications. Specifically, the administration of RLF-OD032 in a fasted state without water resulted in greater absorption of sapropterin dihydrochloride compared to the reference product administered under fed conditions with water. In contrast, KUVAN shows poor absorption when taken with water in a fasted state, as reported in KUVAN's Full Prescribing Information, which recommends that PKU patients take the product exclusively with meals with a large volume of water. These findings indicate that RLF-OD032 could offer new administration options for PKU patients, providing greater flexibility for dosing without the need for food and water. This may improve patient convenience and compliance, allowing them to take their medication anytime, even while on the go. The U.S. provisional patent applications strengthen the intellectual property around RLF-OD032 and complement the Company's existing patent estate. Relief is evaluating the development and regulatory implications of these findings as it continues to advance RLF-OD032 through clinical development with the objective of filing a 505(b)(2) NDA in the U.S. by Q3/2025. ABOUT RLF-OD032 ABOUT PHENYLKETONURIA ABOUT RELIEF CONTACT: DISCLAIMER KUVAN® is a registered trademark of BioMarin Pharmaceutical Inc. The use of this trademark in this press release is for reference purposes only, and Relief has no affiliation, sponsorship, or endorsement from BioMarin Pharmaceutical Inc. All references to KUVAN are made solely for comparison of study results and do not imply any relationship between the companies. Additional features: File: Ad hoc End of Inside Information |
Language: | English |
Company: | Relief Therapeutics Holding SA |
Avenue de Secheron 15 | |
1202 Geneva | |
Switzerland | |
Phone: | +41 22 545 11 16 |
E-mail: | contact@relieftherapeutics.com |
Internet: | https://relieftherapeutics.com |
ISIN: | CH1251125998 |
Valor: | 125112599 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 2015865 |
End of Announcement | EQS News Service |
2015865 25-Oct-2024 CET/CEST