RegeneRx licensee to expand Phase 3 clinical trial program with RGN-259

RegeneRx Biopharmaceuticals Inc. said today 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.

The trials will be sponsored by the U.S. JV, ReGenTree, LLC.

In a news release, the companies noted that RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

To date, more than 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications.

According the HLBT, it will 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, the company said it plans 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.

The company also noted in its news release that 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].

HLBT also noted that 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 in November.

J.J. Finkelstein, RegeneRx's president and CEO, said the company was pleased to see that HLBT is moving forward with both NK and DED clinical trials with RGN-259.

“We believe our product candidate has significant potential as an important therapeutic modality for numerous ophthalmic disorders,” he said in a news release. “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.”