Relief Therapeutics announced the first three patients have been enrolled in a proof-of-concept, investigator-initiated study to evaluate RLF-TD011 as a treatment for epidermolysis bullosa (EB).

The primary aim of the study will be to assess changes in the skin microbiome (Staphylococcus aureus, Pseudomonas aeruginosa, commensal organisms) before, during and after treatment with RLF-TD011.

RLF-TD011 is a self-administered spray enabling targeted application while avoiding skin contact and cross-contamination. Patients with dystrophic or junctional EB whose wounds are colonized by S. aureus and/or P. aeruginosa will be treated with RLF-TD011 for 8 weeks followed by discontinuation of treatment for 4 weeks with assessment of their wound microbiome at each stage. All study participants will have the option to continue treatment in a 6-month open-label study extension.

“EB is a rare, inherited skin disease characterized by widely distributed, painful, chronic wounds that easily become infected, resulting in an elevated risk of sepsis and death. As there is no cure for EB, a crucial element of patient management involves rigorous and timely wound care,” Professor Amy Paller, MD, chair, department of dermatology, Feinberg School of Medicine, Northwestern University and principal investigator of the study, said in a company news release. “We are eager to assess the effect of RLF-TD011 on the microbiome in colonized dystrophic and junctional epidermolysis bullosa wounds and determine tolerability, symptom improvement, reduction of lesion size and wound closure.”

The study is currently enrolling up to 17 patients diagnosed with junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB) with S. aureus or P. aeruginosa culture-positive wounds at Ann & Robert H. Lurie Children's Hospital of Chicago.

“The results of this study will be most valuable for the swift, effective and efficient execution of our clinical development plan for RLF-TD011,” said Nermeen Varawalla, MD, PhD, chief medical officer, Relief Therapeutics. “These data will facilitate the design and conduct of follow-on, multicenter, pivotal registration clinical trials to determine the impact of RLF-TD011 on infection control, avoidance of chronic antibiotic use, accelerated wound healing and quality of life for patients living with EB.”

Additional information about this investigator-initiated study is available at ClinicalTrials.gov (NCT05533866).