New Examine Outcomes Point out Superior Absorption of RLF-OD032 in Fasted State In comparison with KUVAN ®, Probably Enabling Versatile Dosing Choices
GENEVA, SWITZERLAND / ACCESSWIRE / October 25, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Reduction, or the Firm), a biopharmaceutical firm dedicated to delivering modern remedy choices for choose specialty, unmet and uncommon illnesses, at the moment introduced new optimistic medical research outcomes for RLF-OD032 and the submitting of provisional patent purposes in the US. The patents, primarily based on these new findings, cowl further claims for Reduction’s investigational drug RLF-OD032, a extremely concentrated, novel liquid formulation of sapropterin dihydrochloride, for the remedy of phenylketonuria (PKU).
The patent filings comply with the just lately introduced completion of a pilot, proof-of-concept, four-way crossover research that evaluated the pharmacokinetic profile of RLF-OD032 and its absorption in each fasted and fed situations. The Firm beforehand reported that RLF-OD032, when administered in fed situations with out water, achieved peak and complete publicity of sapropterin dihydrochloride much like these achieved by the reference product (KUVAN ® Powder) administered with water.
Immediately, Reduction introduced further optimistic and sudden outcomes from the research that type the premise of those new patent purposes. Particularly, the administration of RLF-OD032 in a fasted state with out water resulted in higher absorption of sapropterin dihydrochloride in comparison with the reference product administered underneath fed situations with water. In distinction, KUVAN reveals poor absorption when taken with water in a fasted state, as reported in KUVAN’s Full Prescribing Data, which recommends that PKU sufferers take the product completely with meals with a big quantity of water.
These findings point out that RLF-OD032 may provide new administration choices for PKU sufferers, offering higher flexibility for dosing with out the necessity for meals and water. This will likely enhance affected person comfort and compliance, permitting them to take their treatment anytime, even whereas on the go.
The U.S. provisional patent purposes strengthen the mental property round RLF-OD032 and complement the Firm’s current patent property. Reduction is evaluating the event and regulatory implications of those findings because it continues to advance RLF-OD032 by means of medical growth with the target of submitting a 505(b)(2) NDA within the U.S. by Q3/2025.
ABOUT RLF-OD032
RLF-OD032 is an modern, ready-to-use, transportable and extremely concentrated formulation of sapropterin dihydrochloride in liquid suspension for oral administration, designed to decrease blood phenylalanine ranges in grownup and pediatric PKU sufferers. It provides a extra patient-friendly resolution by considerably lowering the quantity of treatment required in comparison with present formulations. This development goals to reinforce compliance, significantly amongst pediatric sufferers, who usually battle with the excessive volumes related to current sapropterin therapies. If authorised, RLF-OD032 can be the primary and solely transportable, ready-to-use liquid formulation of sapropterin dihydrochloride.
ABOUT PHENYLKETONURIA
Phenylketonuria (PKU) is a genetic dysfunction attributable to a deficiency of the enzyme wanted to interrupt down phenylalanine (Phe), resulting in a poisonous buildup of Phe from the consumption of meals containing protein or aspartame. People with PKU lack the power to metabolize Phe, which is current in lots of meals. With out remedy, PKU could cause extreme neurological and developmental points. The usual remedy includes a lifelong phenylalanine-restricted eating regimen supplemented with amino acid-based, phenylalanine-free medical meals to stop protein deficiency and optimize metabolic management. Nevertheless, this eating regimen is extremely restrictive and infrequently creates obstacles to social interplay, limiting compliance and growing the danger of poor illness administration. Sapropterin dihydrochloride is the primary authorised drug for PKU for lowering Phe blood ranges and permitting sufferers to comply with a much less restrictive eating regimen.
ABOUT RELIEF
Reduction is a commercial-stage biopharmaceutical firm dedicated to advancing remedy paradigms and delivering enhancements in efficacy, security, and comfort to profit the lives of sufferers dwelling with choose specialty and uncommon illnesses. Reduction’s portfolio provides a balanced mixture of marketed, revenue-generating merchandise, proprietary, globally patented TEHCLO™ and Physiomimic™ platform applied sciences and a focused medical growth pipeline consisting of risk-mitigated property targeted in three core therapeutic areas: uncommon pores and skin illnesses, uncommon metabolic issues, and uncommon respiratory illnesses. As well as, Reduction is commercializing a number of legacy merchandise by way of licensing and distribution companions. Headquartered in Geneva, Reduction is listed on the SIX Swiss Change underneath the image RLF and quoted within the U.S. on OTCQB underneath the symbols RLFTF and RLFTY. For extra data, go to www.relieftherapeutics.com .
CONTACT :
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Monetary Officer
[email protected]
DISCLAIMER
This press launch comprises forward-looking statements. Ahead-looking statements contain recognized and unknown dangers, uncertainties, together with its skill to attain its company, growth and industrial targets, and different components which may trigger the precise outcomes, monetary situation, efficiency or achievements of Reduction to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. Quite a few components, together with these described in Reduction’s filings with the SIX Swiss Change and the U.S. Securities and Change Fee (SEC), may adversely have an effect on Reduction. Copies of Reduction’s filings with the SEC can be found on the SEC EDGAR database at www.sec.gov . Reduction doesn’t undertake any obligation to replace the data contained herein, which speaks solely as of this date.
KUVAN ® is a registered trademark of BioMarin Pharmaceutical (NASDAQ:) Inc. Using this trademark on this press launch is for reference functions solely, and Reduction has no affiliation, sponsorship, or endorsement from BioMarin Pharmaceutical Inc. All references to KUVAN are made solely for comparability of research outcomes and don’t suggest any relationship between the businesses.
SOURCE: Reduction Therapeutics Holding SA
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