RegeneRx is a virtual biopharmaceutical company focused on tissue protection, repair and regeneration. While historically developing novel pharmaceuticals that protect and repair tissue and organ damage caused by disease, trauma or other pathology, the Company’s primary focus is on Thymosin beta 4 (Tβ4) to treat ophthalmic indications such as neurotrophic keratitis (NK) and dry eye disease (DED).
Currently, RegeneRx has active partnerships in four major territories: the U.S. and Canada, China and Pan Asia and the EU. Our ophthalmic drug candidate, RGN-259, is in phase 3 clinical trials in the U.S. and EU for the treatment of NK, an orphan indication. RGN-259 is the subject of a U.S. joint venture (ReGenTree LLC) between RegeneRx and HLB Therapeutics, a Korean biopharmaceutical company and licenses throughout Asia. ReGenTree is sponsoring the clinical development of RGN-259 in the U.S. and the cost of development is being borne by our partner with no financial obligation for RegeneRx. Results are targeted for early 2024.
Clinical results in patients with NK treated with RGN-259 have previously demonstrated efficacy in a small number of patients (18) in the first phase 3 clinical trial (SEER-1). Based on these results, two independent clinical trials are underway designed to confirm SEER-1 and significantly shorten the clinical development period (SEER-2 and SEER-3). The double-masked, placebo-controlled trials will be conducted by administering RGN-259 or placebo eye drops for four weeks to approximately 70 NK patients in each trial, with a primary endpoint of "complete corneal healing." Considering it is a rare disease, ReGenTree plans to recruit more than 30 clinical institutions in the U.S. to accelerate patient recruitment. See www.clinicaltrials.gov for more information.
RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratitis. To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications. Thymosin beta 4, is the active pharmaceutical ingredient of RGN-259 that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties.