Research & Development
HLB Therapeutics plans to expand RGN-259 ophthalmic clinical development program in two indications
23 June 2022 -

RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug development company, announced on Wednesday that its United States joint venture (JV) partner and licensee, HLB Therapeutics (HLBT), is planning to expand its ophthalmic clinical development program with RGN-259 in two indications, Neurotrophic Keratopathy (NK) and Dry Eye Disease (DED), from November 2022.

The United States joint venture, ReGenTree, LLC, will be sponsoring the trials.

HLBT said, 'Although we at ReGenTree had focused on dry eye clinical trials in recent years, we now plan to run both DED and NK clinical development program simultaneously. In the case of DED, for which ReGenTree conducted a pre-BLA meeting in February this year, we plan to apply for SPA (Special Protocol Assessment) to the FDA around this October. SPA is a program in which FDA specialists provide a sponsor (ReGenTree) with collaboration in setting up clinical protocols and statistical analysis plans. The agreed clinical trial design with FDA is binding and this program will give the sponsor and FDA a clear understanding [of relevant trial criteria] by participating together at this stage of the clinical trial protocol development.'



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