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news.RegeneRx Biopharmaceuticals' US joint venture with G-treeBNT (ReGenTree) has retained Ora to conduct a Phase III trial for the orphan disorder, neurotrophic keratopathy (NK) as well as a Phase IIb/III dose-response, confirmatory trial for dry eye syndrome (DES) in the US.
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In 2015, the two trials will be examining, RGN-259/GBT201, ReGenTree’s preservative-free eye drops.
Each of these eye disorders was being targeted by RegeneRx before entering into the joint venture.
Pervious clinical trials with RGN-259 (thymosin beta 4 ophthalmic solution) have showed the drug candidate’s ability to improve both signs and symptoms of DES and identified co-primary endpoints to be targeted in the DES trials.
Results of a small physician-sponsored Phase II trial in patients with severe dry eye have showed significant improvements in patients’ signs and symptoms.
Ora has developed a controlled adverse environment (CAE) model for dry eye allowing rapid recruitment, treatment and evaluation of patients with DES.
Earlier, Ora conducted a 72-patient Phase II dry eye trial with RGN-259 on behalf of RegeneRx.