RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting today that its U.S. joint venture (JV) partner and licensee, HLB Therapeutics (HLBT), has signed a letter of intent with a global ophthalmology contract research organization (CRO) to conduct two phase 3 clinical trials simultaneously beginning in the Fall 2022 in the U.S. and Europe for patients with neurotrophic keratitis (NK).
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The FDA requires two successful phase 3 trials in most circumstances prior to submitting a new drug or biologics application (NDA/BLA). The purpose of conducting simultaneous trials is to reduce the time required to complete phase 3.
“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, HLBT decided to conduct two clinical trials for NK at the same time because it is expected that RGN-259 would have a high possibility of success in this disease. Unlike dry eye disease, clinical studies for neurotrophic keratitis require a very simple and clear single primary endpoint, such as complete healing,” according to HLBT.
Currently, Oxervate, developed by Dompé, is the only available treatment for NK in the United States. However, the cost for Oxervate is very expensive, approaching $50,000 per month. The CRO, which signed the letter of intent with ReGenTree, a U.S. joint venture between RegeneRx and HLBT, participated in the clinical trial of Oxervate and has clinical experience and expertise in NK clinical trials. Neurotrophic Keratitis is a relatively large market for rare diseases as about 20,000 patients contract this disease annually in the United States.
In October 2022, ReGenTree plans to apply to the FDA for a Special Protocol Assessment (SPA) for an additional dry eye trial (ARISE-4). The SPA program allows FDA specialists to provide input and collaborate with a sponsor (ReGenTree) in setting up clinical protocols and statistical analysis plans, which is binding. By participating together at this stage of the protocol development, the sponsor and FDA have a clear understanding of the requisite trial protocol.
“We are pleased HLBT is continuing to move forward with both NK and DED clinical trials with RGN-259 as previously discussed. 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,” stated J.J. Finkelstein, RegeneRx’s president and chief executive.