RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") today announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. The Company believes clinical trials could be started by mid-2015.
As is typically required by FDA, the Company is planning to conduct two pivotal phase 3 trials, anticipated to total less than 90 patients to confirm the safety and efficacy of RGN-259 for NK. It is estimated that each trial will take approximately six to nine and months will be designed based on the results of an earlier trial conducted by ophthalmologists at Wayne State University and Beaumont Hospital in Detroit, MI. In moving from Phase 2 to Phase 3 the Company, through its contractors, intends to expand CMC efforts (chemistry, manufacturing, and controls) as required by FDA regulations. RegeneRx has been working with Ora Inc., a global ophthalmic research and product development firm, to develop the regulatory pathway and implement the clinical development plan on this orphan indication. RegeneRx recently retained Ora as CMC consultant and has begun evaluating manufacturers with Phase 3 and commercial production capabilities for this product. The Company plans to submit a CMC plan and final clinical protocol to FDA at the earliest practicable time.
"We are very pleased that we can begin Phase 3 clinical trials with RGN-259, which has shown promise in treating patients with NK, as well as with dry eye syndrome. The FDA was very helpful by providing guidance for Phase 3, which it has done throughout development of this product. We believe the development of RGN-259 for NK, an orphan disease in the U.S. and EU, offers the best and fastest opportunity for commercialization in the U.S. while we await the development of RGN-259 for dry eye syndrome by our two partners in their respective licensed territories. We also look forward to continuing discussions with ophthalmic and pharma companies that have been following our recent progress in this field." stated J.J. Finkelstein, RegeneRx's president and chief executive officer. "As reported in our regulatory filings, we would need to raise additional capital to fully implement this Phase 3 program, or enter a strategic partnership with a company having the resources and capabilities necessary for development of RGN-259," Mr. Finkelstein added.
"NK is a degenerative disease that can cause serious damage to the eye if left untreated, with stromal melting leading to perforation and/or ulceration," said George Ousler, vice president, dry eye at Ora, Inc. "Continuing to show positive results in Phase 3 will be an important breakthrough for treating NK. We are also excited about the initial results in dry eye patients and the opportunity for development of RGN-259 for this underserved patient population."
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