RegeneRx is developing RGN-137, a topical gel formulation of the peptide Tβ4, as a novel treatment to accelerate dermal healing.

RGN-137 represents a new approach to dermal healing as it is not a growth factor. Unlike growth factors, RGN-137 has been shown in preclinical studies to affect multiple dermal healing pathways, such as apoptosis, angiogenesis, collagen deposition, and inflammation. The gene for Tβ4 has also been shown in preclinical studies to be one of the first to be upregulated when an injury occurs, suggesting that the peptide may contribute to the healing process.

A phase 1 clinical trial, completed in 2004, showed no serious adverse events (SAEs) and no drug-related adverse events (AEs) in healthy, normal subjects. To date, over 170 patients have been dosed with RGN-137 with no drug-related AEs or SAEs.

Phase 2 clinical trials for the treatment of pressure ulcers and venous stasis ulcers were completed in 2009. A phase 2 trial for the treatment of Epidemolysis Bullosa is still ongoing.

RGN-137 Topical
Pressure Ulcers
Venous Stasis U.
E. Bullosa