RegeneRx Biopharmaceuticals announced the first patient enrolled in a Phase 2 clinical trial of RGN-137, the company’s investigational topical gel for treating epidermolysis bullosa (EB), achieved complete wound healing.
RGN-137 is a gel form medication intended to accelerate wound healing when applied directly on skin lesions. It is based on thymosin beta-4 (Tβ4), a lab-made version of a protein naturally produced in the body that has been shown to have strong wound-healing and anti-inflammatory properties.
The randomized, single-blind, placebo-controlled, self-matched pairing Phase 2 trial (NCT03578029) is being sponsored by Lenus Therapeutics, a subsidiary U.S. joint venture of the Korean companies Yuyang DNU and GtreeBNT. RGN-137 is currently being developed under a license from RegeneRx to GtreeBNT in the U.S., Canada, Europe, Korea, Japan, and Australia for several wound-healing indications.
The Phase 2 trial is being carried out at five EB expert hospitals in the U.S. and is currently recruiting patients age 4 or older who have either junctional or dystrophic epidermolysis bullosa (JEB and DEB). More information on trial locations and contacts is available here.
Participants will be treated with both RGN-137 and a placebo (a topical gel that lacks RGN-137’s active ingredient), which will be applied to wounds of roughly the same size at similar developmental stages. The study has an open design, which means that even though patients are unaware of which product is being applied to each of their wounds, the trial’s sponsor and investigators administering the medication know the difference.
RegeneRx and Lenus have now confirmed the first patient who was enrolled in the trial and started treatment earlier this year achieved complete healing of the wound treated with RGN-137, but not in the wound treated with a placebo. This observation confirms the clinical superiority of RGN-137 in accelerating wound healing in patients with EB, compared to a placebo.
“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,” an unnamed official of Lenus said in a press release.
RGN-137 previously received the designation of orphan drug from the U.S. Food and Drug Administration, which also has approved the launch of the upcoming Phase 3 trial in the U.S. for the investigational therapy. RegeneRx is making plans for the new trial, which will build on data generated by the ongoing Phase 2 study.