Relief Therapeutics Holding SA announced positive final results from its proof-of-concept clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds. The trial, focusing on junctional and dystrophic EB, met its primary endpoint, demonstrating a significant reduction in Staphylococcus aureus abundance and promoting wound closure.
Clinical Trial Results
The trial evaluated the effects of RLF-TD011 on microbiome diversity in chronic and acute wounds in EB patients. After eight weeks of treatment, RLF-TD011 led to a 24% decrease in S. aureus relative abundance (p=0.01), which correlated strongly (rho=0.64) with wound size reduction. Overall, 78% of treated wounds closed during the treatment period.
Microbiome analysis further showed that RLF-TD011 treatment led to a marked increase in alpha diversity, with an increase in beneficial bacteria within the wound microbiome, effectively reducing S. aureus without disrupting beneficial bacteria. Improvements in microbiome diversity persisted through a four-week post-treatment observation period, evidencing RLF-TD011's durability effect on the wound environment without signs of regression or exacerbation.
Expert Commentary
"Epidermolysis bullosa is a devastating blistering skin disease that greatly impairs quality of life, particularly from the pain, itch, and risk of infection associated with open wounds. Evidence of reduction in the load of S. aureus and associated improved wound closure highlights the value of use of an antimicrobial spray during wound care," said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University in Chicago, U.S.
RLF-TD011: Mechanism and Potential
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. It is designed as a sprayable, self-administered solution for targeted wound application, aiming to control infection and inflammation while reducing antibiotic use and easing the intensive wound care routine required by current treatments. The U.S. Food and Drug Administration has granted RLF-TD011 orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.
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. Approximately 500,000 individuals worldwide are affected by EB.
