RegeneRx Biopharmaceuticals Inc. reported 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). 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. 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.