Lenus Therapeutics, LLC is currently recruiting for a Phase 2 Clinical Trial for evaluation of the safety and efficacy of RGN-137. RGN-137 is topical hydro gel formulation, containing 0.03% Thymosin beta-4 (Tb4), a naturally occurring peptide produced by the body which has wound healing and anti-inflammatory properties. Tb4 is found in all tissues and in all cell types, the blood, and other body fluids. Tb4 contains 43 amino acids. It appears to have a wide range of regenerative activities, like anti-inflammation, re-epithelialization, and especially, promotions/acceleration of wound repair. The gene for Tb4 has also been found to be one of the first to be upregulated after a wound occurs. It promotes/accelerates wound repair and regeneration in dermal, ocular, cardiac, and CNS animal models as well as in clinical trials for eye and dermal injuries.
RGN-137 will be evaluated for efficacy and safety compared to a Placebo for 15 subjects with JEB or DEB. Eligible subjects must be 4 years and older and have 1 set of pair wounds of similar size but no necessarily in similar locations. The investigator will select the pair of wounds, and one wound will be applied RGN-137 gel and the other will be applied Placebo gel once a day for up to 84 days. Patients will be blinded to the treatment assignments for each wound, however there is no chance to be treated with only placebo. The maximum study duration for each subject will be approximately 16 weeks and includes a screening period of 2 weeks (7 to 14 days prior to baseline Visit), a treatment period of 12 weeks, and a follow-up period of 2 weeks. There are no blood draws, and the patients can use whatever bandaging they prefer.
- Male or female and at least 4 years old with a diagnosis of DEB or JEB
- Patients and their parents or guardians must be willing and able to provide written informed consent/assent
- Presence of 1 pair of stable index wounds within the specified size range at study
- Index wounds must have a surface area between 5 cm2 and 50 cm2, inclusive at the screening visit
- The index wounds selected as pairing must be relatively matched in terms of size and location
- Women of childbearing potential must have a negative pregnancy test prior to randomization
- Sexually active subjects must agree to use medically accepted methods of contraception during the study
- Please click the link below for exclusion criteria.