RegeneRx Biopharmaceuticals has enrolled the first patient in a Phase 3 clinical trial (ARISE-2 trial) with RGN-259 (Thymosin beta 4), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), besides other corneal disorders.
The primary endpoints of the ARISE-2 trial are the change in ocular discomfort and the change in inferior corneal staining at baseline (prior to first dose) and at the end of treatment (after last dose) in a controlled adverse environment (CAE).
They are the same efficacy assessments under CAE that showed strong statistical significance in the Phase 2b/3 trial (ARISE-1) that was reported earlier this year.
The double-masked, placebo-controlled trial is being sponsored by ReGenTree, a joint venture between RegeneRx and GtreeBNT, a Korean biopharmaceutical company and is being conducted by Ora, an established contract research organization specializing in the field of ophthalmology.
ARISE-2 is being conducted at multiple sites in the U.S., will enroll approximately 500 dry eye patients, and is expected to be completed and patient data reported in Q4 2017.
There will be numerous secondary endpoints and other safety and efficacy parameters that will also be evaluated pursuant to the trial protocol.
RegeneRx president and chief executive officer J.J. Finkelstein said: "The start of this second trial, which we've named "ARISE-2," is another significant milestone for RegeneRx and our U.S. joint venture, ReGenTree.
“Our partners at GtreeBNT have done an excellent job diligently moving RGN-259 into late stage clinical trials, which also necessitated conducting numerous ancillary projects required by government regulations that are less visible but quite comprehensive in scope. We expect ARISE-2 to be completed during Q4 2017 and look forward to reporting material events along the way.”
Thymosin beta 4 (Tβ4), the active ingredient in RGN-259, is a first-in-class, naturally occurring molecule that has been the subject of numerous published animal studies in the fields of ophthalmology, dermatology, cardiology, and central nervous system disorders, among others.
In addition to the animal studies, the molecule has been tested in three unique formulations and routes of administration in approximately 650 patients and has an excellent safety profile.