The patent claims are directed to the composition of matter and methods of use, including inhibiting tissue damage caused by ultraviolet radiation and promoting neurite outgrowth and neuron survival, among others. The patent expiry is expected to be 2029.
"This is a very biologically active peptide fragment of TB4 as indicated in a number of animal models that we believe has properties that could be useful in both medical, as well as cosmeceutical, product candidates," stated Dr. Allan L. Goldstein, Emeritus Chairman of the Department of Biochemistry and Molecular Medicine at the George Washington University School of Medicine and RegeneRx’s chief scientific advisor.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration.
RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the U.S., and has an extensive worldwide patent portfolio covering its products.
RGN-259, the Company’s TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK), which is a primary focus of RegeneRx’s clinical development efforts in the U.S through its joint venture, ReGenTree.
RegeneRx was recently allowed by the FDA to move into Phase 3 clinical trials with RGN-259 for the treatment of patients with NK. RGN-352, the Company’s TB4-based injectable drug candidate, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar injuries.