US-based clinical-stage drug development company RegeneRx has begun enrolment in its Phase III ARISE-2 trial of RGN-259 (Thymosin beta 4) to treat dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.
The primary endpoints of the ARISE-2 study are the change in both ocular discomfort and 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, which indicated strong statistical significance in the Phase 2b/3 trial (ARISE-1) that was reported earlier this year.
Sponsored by ReGenTree, a joint venture between RegeneRx and Korean biopharmaceutical company GtreeBNT, the double-masked, placebo-controlled trial is being conducted by Ora, a contract research organisation specialising in the field of ophthalmology.
ARISE-2 is being conducted at multiple sites in the US. It will see the enrolment of around 500 dry eye patients and is expected to be completed with patient data reported in the fourth quarter of 2017.
There will be several secondary endpoints and other safety and efficacy parameters that will also be evaluated pursuant to the trial protocol.
RegeneRx president and CEO JJ Finkelstein said: "The start of this second trial, which we have named ARISE-2, is another significant milestone for RegeneRx and our US 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 the fourth quarter of 2017 and look forward to reporting material events along the way."
RGN-259 is a Tβ4-based sterile and preservative-free eye drop developed to treat ophthalmic ailments such as dry eye and neurotrophic keratitis (NK).
Image: Person with severe dry eye syndrome. Photo: courtesy of Jesse Vislisel, MD and Brice Critser, CRA.