Phase II/III trial of RGN 259 (thymosin beta 4) for the treatment of dry eye fails to meet endpoint-RegeneRx Biopharmaceuticals
RegeneRx Biopharmaceuticals announced positive results from its second clinical trial evaluating RGN 259 (thymosin beta 4) for the treatment of dry eye sponsored by ReGenTree LLC, its U.S. joint venture with GtreeBNT in Korea. The 317-patient Phase II/III trial (ClinicalTrials.gov Identifier: NCT02597803) demonstrated statistically significant improvements in both signs and symptoms of dry eye with 0.05% and 0.1% RGN 259 compared to placebo in a dose dependent manner during a 28-day dosing period. While the primary outcome measures were not met, several key related pre-specified endpoints and subgroups of patients with more severe dry eye showed statistically significant treatment effects. These results confirm the findings from the previous Phase II trial providing clear direction for the clinical regulatory pathway and remaining registration trials for RGN-259.
RGN 259 was evaluated using the Controlled Adverse Environment (CAE) Model. A statistically significant ocular discomfort improvement after CAE exposure on Day 28 was also observed in the 0.05% and 0.1% RGN 259 treatment arms when compared to placebo indicating a dose dependent response. Efficacy in an environmental setting was also demonstrated in more symptomatic patients at baseline, with statistically significant improvements in ocular discomfort observed at day 28 prior to CAE in patients receiving 0.05% and 0.1% RGN 259 versus placebo.
RGN 259 also improved a common objective endpoint – ocular surface staining after 28 days of dosing in patients with compromised tear film break-up time at baseline. There were no significant drug-related adverse or serious adverse events and RGN 259 was well-tolerated and comfortable for the patients with no irritation upon instillation. ReGenTree intends to meet with the FDA this summer to provide full results of the trial and its plan to conduct a confirmatory Phase III study to start by the 4th quarter of 2016.
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