UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the Month of October, 2024
Commission File Number: 001-41174
RELIEF THERAPEUTICS Holding SA
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of registrant’s name into English)
Switzerland
(Jurisdiction of incorporation or organization)
Avenue de Sécheron 15
1202 Geneva
Switzerland
Tel: +41 22 545 11 16
(Address of principal executive offices)
Indicate by check mark if the registrant files or
will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On October 25, 2024, the
Company issued a press release entitled “Relief Therapeutics Reports New Study Results for RLF-OD032 and Files Provisional
Patents.” A copy of the press release is attached to this Form 6-K as Exhibit 99.1.
INDEX TO EXHIBITS
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SIGNATURES
Pursuant to the requirements of the Securities Exchange
Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
RELIEF THERAPEUTICS Holding SA
By: /s/ Jeremy Meinen
Jeremy Meinen
Chief Financial Officer
Dated: October 28, 2024
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Exhibit 99.1
Ad hoc announcement pursuant to Art. 53 LR
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
RLF-OD032 is an innovative, 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. It offers a more patient-friendly solution by significantly
reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance,
particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If
approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.
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ABOUT PHENYLKETONURIA
Phenylketonuria (PKU) is a genetic disorder
caused by a deficiency of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the
consumption of foods containing protein or aspartame. Individuals with PKU lack the ability to metabolize Phe, which is present in
many foods. Without treatment, PKU can cause severe neurological and developmental issues. The standard treatment involves a
lifelong phenylalanine-restricted diet supplemented with amino acid-based, phenylalanine-free medical foods to prevent protein
deficiency and optimize metabolic control. However, this diet is highly restrictive and often creates barriers to social
interaction, limiting compliance and increasing the risk of poor disease management. Sapropterin dihydrochloride is the first
approved drug for PKU for reducing Phe blood levels and allowing patients to follow a less restrictive diet.
ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical
company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the
lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed,
revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a
targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin
diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products
via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF
and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com
DISCLAIMER
This press release contains forward-looking
statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its
corporate, development and commercial goals, and other factors which could cause the actual results, financial condition,
performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or
implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX
Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s
filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the
information contained herein, which speaks only as of this date.
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.
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