RegeneRx Biopharmaceuticals has announced that the Canadian Patent Office has issued a Notice of Allowance for Thymosin beta 4 (Tβ4) for use in the treatment of neurological injury and damage. Tβ4 is the active pharmaceutical ingredient in RegeneRx’s proprietary drug candidate, RGN-352, a first-in-class product candidate designed for systemic administration to patients suffering from neurological injuries and damage, including stroke and trauma.
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, 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 the US, China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.
RegeneRx, through its US joint venture, ReGenTree LLC, completed patient enrolment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, reported positive clinical results, and has scheduled a meeting with the US FDA in April 2018. ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK) targeted for completion in 2018. Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx’s two Asian partnerships. RGN-259 has been designated an orphan drug in the US for the treatment of NK.
RGN-352, the Company’s Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.
RGN-137, also designated an orphan drug in the US, is the Company’s Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company’s licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the US and is expected to initiate the study in 2018.