RLF-TD011, a hypochlorous acid spray developed by Relief Therapeutics, has demonstrated effectiveness in controlling infections and promoting wound healing in patients with junctional or dystrophic epidermolysis bullosa. A Phase 1 clinical study (NCT05533866) revealed that the spray significantly reduced harmful bacteria in adults and children with these forms of the disease.
The investigator-initiated study assessed the efficacy of RLF-TD011 in reducing Staphylococcus aureus bacteria in open wounds of 16 patients over an eight-week treatment period. The results indicated a notable decrease in bacterial load and improved wound closure.
Phase 1 Trial Results
The Phase 1 trial met its primary endpoint, demonstrating a 24% reduction in the number of S. aureus bacteria in the wounds after eight weeks of treatment. This reduction was correlated with improved wound closure, with 78% of treated wounds showing complete closure.
"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 Amy Paller, MD, the study’s principal investigator and chair of dermatology at Northwestern University in Chicago.
Following the eight-week treatment, researchers observed a shift towards a more diverse microbiome in the wounds, characterized by an increase in beneficial bacteria. This suggests that RLF-TD011 may have a sustained positive impact on the wound environment.
Regulatory and Clinical Context
Epidermolysis bullosa is a rare genetic disorder characterized by fragile skin that blisters and tears easily, leading to chronic wounds that are prone to infection. The junctional and dystrophic forms are particularly severe, often resulting in significant pain and impaired quality of life.
"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," Paller added.
RLF-TD011, developed using Relief's Tehclo technology, is a highly pure solution of hypochlorous acid, a naturally occurring antimicrobial produced by the immune system. The spray formulation allows for easy, touch-free application, minimizing the risk of further infection.
Future Directions
Relief Therapeutics intends to consult with the U.S. Food and Drug Administration (FDA) to finalize the development and regulatory plan for RLF-TD011. The FDA granted the spray orphan drug designation in 2019, providing benefits such as tax credits and seven years of market exclusivity upon approval.
"These findings support the potential of RLF-TD011 to meaningfully advance wound care for patients with epidermolysis bullosa," said Giorgio Reiner, chief scientific officer of Relief.
