Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011

Rhea-AI Summary

Relief Therapeutics (RLFTY) has received FDA Rare Pediatric Disease (RPD) designation for RLF-TD011, targeting epidermolysis bullosa (EB), a rare genetic skin disorder. RLF-TD011 is a hypotonic acid-oxidizing solution with hypochlorous acid, designed to provide antimicrobial and anti-inflammatory benefits for wound healing. The treatment previously received Orphan Drug Designation and has shown promising clinical results in modulating wound microbiome. The RPD designation applies to diseases affecting fewer than 200,000 people under 18 in the US. If approved, Relief could receive a Priority Review Voucher (PRV), which can be sold - notably, a similar PRV for an EB treatment was recently sold for $155 million in May 2025.

Positive

• FDA granted Rare Pediatric Disease designation, following previous Orphan Drug Designation
• Potential to receive Priority Review Voucher (PRV) worth significant value, as evidenced by recent $155M sale of similar EB treatment PRV
• Promising clinical findings showing effective wound care through microbiome modulation

Negative

• PRV eligibility subject to congressional reauthorization for designations after December 2024
• Treatment still in early stages, pending pre-IND meeting

GENEVA, SWITZERLAND / ACCESS Newswire / May 22, 2025 / 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 U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder characterized by fragile skin and chronic wounds. The FDA had previously granted Orphan Drug Designation to RLF-TD011 for the same indication.

RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti-inflammatory activity while creating a wound microenvironment conducive to healing. The Company previously reported promising clinical findings supporting RLF-TD011's potential to meaningfully advance EB wound care by modulating the wound microbiome and reducing pathogenic colonization without disrupting beneficial bacteria.

"The FDA's decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy," said Giorgio Reiner, chief scientific officer of Relief. "We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting."

The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible-subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024-to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million.

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, and Relief plans to seek Qualified Infectious Disease Product (QIDP) designation for extended market exclusivity.

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.

SOURCE: Relief Therapeutics Holding SA

View the original press release on ACCESS Newswire

FAQ

What is the FDA Rare Pediatric Disease designation received by Relief Therapeutics (RLFTY)?

The FDA granted Rare Pediatric Disease designation to Relief's RLF-TD011 for treating epidermolysis bullosa (EB), a rare genetic skin disorder. This designation is for diseases affecting fewer than 200,000 people under 18 in the US.

What is RLF-TD011 and how does it treat epidermolysis bullosa?

RLF-TD011 is a hypotonic acid-oxidizing solution containing hypochlorous acid that provides antimicrobial and anti-inflammatory activity. It helps in EB treatment by modulating the wound microbiome and reducing harmful bacteria while preserving beneficial ones.

What potential financial benefit could Relief Therapeutics receive from the RPD designation?

If approved, Relief could receive a Priority Review Voucher (PRV), which can be sold. A similar PRV for an EB treatment was recently sold for $155 million in May 2025.

What previous FDA designations has Relief's RLF-TD011 received?

Prior to receiving the Rare Pediatric Disease designation, RLF-TD011 had already received Orphan Drug Designation from the FDA for treating epidermolysis bullosa.

What is the current development stage of Relief Therapeutics' RLF-TD011?

RLF-TD011 is still in early development stages, with the company planning to discuss next steps in their development plan during an upcoming pre-IND meeting with the FDA.