Relief Therapeutics Receives FDA Response to QIDP Request for RLF-TD011 20.06.2025, 07:00 Uhr von EQS News Jetzt kommentieren: 0

Relief Therapeutics Receives FDA Response to QIDP Request for RLF-TD011
 

GENEVA (June 20, 2025) – 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 that its initial request for Qualified Infectious Disease Product (QIDP) designation for RLF-TD011 for the treatment of epidermolysis bullosa (EB) was not granted by the U.S. Food and Drug Administration (FDA). The FDA determined that the investigational therapy does not currently meet the criteria for QIDP designation.

This outcome does not impact the Company’s development and regulatory strategy for RLF-TD011. The program continues to benefit from both Orphan Drug and Rare Pediatric Disease designations, which provide important regulatory and commercial incentives, including the potential for seven years of market exclusivity in the United States upon approval. RLF-TD011 is further supported by the Company’s intellectual property portfolio, including a recently granted European patent providing protection through 2040.

The Company also reported that it held a constructive pre-Investigational New Drug (pre-IND) meeting with the FDA. Discussions focused on the remaining clinical and regulatory steps required to advance RLF‑TD011 into later-stage development. Relief expects to complete the pre-IND meeting process upon receipt of the FDA’s written responses in the coming weeks.

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 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. Relief's acid-oxidizing solution has previously 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. The U.S. Food and Drug Administration has granted RLF-TD011 both Orphan Drug and Rare Pediatric Disease designations for EB.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief’s clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. 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, 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.