RegeneRx Biopharmaceuticals Provides Update On Clinical Trials

RegeneRx Biopharmaceuticals, Inc. recently provided an update on the status and timing of the four ophthalmic clinical trials for dry eye syndrome and neurotrophic keratopathy (NK) scheduled to commence in the US, Korea, and China this year. In Korea and China, the dry eye trials are being sponsored by RegeneRx’s strategic partners in their respective territories. In the US, the dry eye and NK clinical trials are being sponsored by ReGenTree, LLC, a joint venture between RegeneRx and G-treeBNT. RGN-259/GBT-201 is a sterile, preservative-free ophthalmic eye drop that is being tested in the trials.

Representatives of G-treeBNT and RegeneRx recently met with the US Food and Drug Administration to finalize details of the Phase IIb/III trial in patients with dry eye syndrome, which is being sponsored by ReGenTree, LLC. Based on the positive outcome of the meeting, ReGenTree is preparing to enroll patients in the US dry eye and NK clinical trials in September 2015. The Phase IIb/III dry eye trial is expected to be completed during the first half of 2016, and the Phase III NK trial is expected to be completed in the second half of 2016, or sooner, depending on the speed of patient accrual for this orphan indication.

Additionally, ReGenTree has successfully completed the manufacturing required for Phase III and RGN-259 will soon be shipped to the contract research organization (CRO) managing the clinical trials in the US.

G-treeBNT recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase IIb/III clinical trial for dry eye syndrome in Korea. Given the immediate focus of the two US trials, GtreeBNT is considering the best timing of the Korean trial.

The fourth clinical trial, a Phase II dry eye trial in China is awaiting clearance to start enrollment by the Chinese Food and Drug Administration (CFDA). RegeneRx intends to provide further updates on all trials as appropriate.

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 US, and has an extensive worldwide patent portfolio covering its products. RGN-259, the company’s T4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK). RegeneRx was recently allowed by the FDA to move into Phase III clinical trials with RGN-259 for the treatment of patients with NK. The drug candidate is also being studied in patients with dry eye syndrome in the US and Asia. RegeneRx, through its US joint venture, ReGenTree LLC, is developing RGN-259 in the US and expects to initiate a Phase IIb/III trial later this year. RGN-352, the company’s TB4-based injectable, is a Phase II-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 traumatic injuries. For more information, visit www.regenerx.com.