RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the European Patent Office (EPO) has issued a Decision to Grant for its patent application titled "Therapeutic Uses of Oxidizing Hypotonic Acid Solutions."
This patent will protect therapeutic applications of Relief's proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 for the treatment of wounds caused by epidermolysis bullosa (EB) in key European countries.
The EPO is expected to formally issue the patent on February 26, 2025, under patent number EP 3993811. The patent will remain in effect until 2040, as anticipated by the Notice of Allowance received in October 2024. Corresponding patent applications are under review in other major markets, including the United States and China.
RLF-TD011 has previously received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of EB. The Company also intends to seek qualified infectious disease product (QIDP) designation from the FDA. These designations would provide potential incentives such as market exclusivity upon approval.
Relief continues to advance the development of its lead program and recently reported positive results from its investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of EB. The Company is currently preparing a pre-IND meeting package for submission to the FDA to finalize the remaining clinical development and regulatory strategy for RLF-TD011.
ABOUT RLF-TD011 RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has demonstrated efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In an investigator-initiated trial (NCT05533866), RLF-TD011 has also shown promising results in infection control and wound healing in EB patients with the most severe forms of the disease. RLF-TD011 aims to address unmet needs in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments.
ABOUT EPIDERMOLYSIS BULLOSA Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin's layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB.
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.
DISCLAIMER This press release contains forward-looking statements, which may be identified by words such as "believe," "assume," "expect," "intend," "may," "could," "will," or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
