RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting that its U.S. 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), beginning in November of 2022. The trials will be sponsored by the U.S. JV, ReGenTree, LLC.
The following is information provided to RegeneRx by HLBT, with minor edits and insertion of bracketed clarifications by the Company:
According the HLBT, “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.”
“In addition, ReGenTree will start the two phase 3 trials for NK simultaneously [to meet the requirement of two independent phase 3 clinical trials necessary for FDA marketing approval]. ReGenTree will seek to confirm the efficacy observed in SEER-1 despite the very small number of subjects in that trial. Based on the results of the SEER-1 study, ReGenTree has developed a plan to enter into two phase 3 studies (SEER-2, SEER-3) simultaneously with 60 patients in each study. To this end, it plans to retain a contract research organization (CRO) very shortly and start recruitment of patients around this November.”
“We are pleased HLBT is moving forward with both NK and DED clinical trials with RGN-259 as we believe our product candidate has significant potential as an important therapeutic modality for numerous ophthalmic disorders. Accelerating NK clinical development by simultaneously conducting two trials will speed up the process while also working with the FDA under an SPA to refine our approach to DED. I believe this strategy indicates that HLBT is fully committed to RGN-259’s clinical development in the field of ophthalmology,” stated J.J. Finkelstein, RegeneRx’s president and chief executive.