Lenus Therapeutics, LLC, a US-based joint venture between GtreeBNT and Yuyang DNU in Korea, has confirmed complete wound healing of the index lesion of the first subject enrolled in its ongoing single-masked Phase 2 clinical trial with RGN-137 dermal gel for Epidermolysis Bullosa (EB).
The ongoing Phase 2 clinical trial in the US is proceeding well at five hospitals specializing in EB, Lenus reports.
EB is a rare hereditary disease where the patients suffer from skin fragility. The skin is easily blistered due to gene mutations in proteins important in epidermal and dermal integrity, resulting in severe pain in both the skin and mucous membranes. There are approximately 500,000 patients worldwide with the US and European countries having approximately 50,000 patients. No specific treatment is available beyond supportive care, such as sterile dressing and antibiotics.
The ongoing clinical trial is a single-masked study where two wounds are selected from each patient with one wound treated with placebo and the other with RGN-137 dermal gel. The design is an open study where the results can be confirmed for each patient in parallel with the clinical progression. "The first patient was enrolled, treated, and then confirmed the effect of complete wound healing in one wound but not in the other," said an official at the Company, in a news release.
The new drug "RGN-137” aims to be the first approved product for EB treatment based on its multiple mechanisms of actions, such as promotion of wound healing, cell protection, cell migration, and tissue integrity.
"The achievement of the complete healing in the first enrolled patient is very significant as the upcoming Phase 3 study design will be based on the results of the current ongoing open study. The experiences and findings in the present study will provide the information for defining the clinical study design for the phase 3 study. Thus, RGN-137 will potentially relieve the suffering related to the non-healed wounds of EB pediatric patients," adds an official at the Company.