RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug research company centered on tissue protection, repair as well as regeneration, today announced that GtreeBNT, its Korean partner in the U.S. dry-eye disease development RGN-259, has released an update on the U.S. phase 3 clinical trial. GtreeBNT given the following translation to RegeneRx with some clarifications from RegeneRx:
The continuing dry eye clinical trial (ARISE-3) is moving smoothly as planned. They made important efforts in the second and third quarters of 2019 to select suitable clinical study locations and identified and chosen approximately 15 eye hospitals as study locations and initiated clinical trials sequentially. Furthermore, by actively using hospital databases to select patients who fulfill the requirements for hiring clinicians and by efficiently and effectively asking questions to better define the patient status learned from ARISE-1 and ARISE-2, in this ARISE-3 clinical trial, we are becoming more effective and precise with patient testing. Furthermore, as we focus more fully on clinical leadership based on the know-how, we have learned from the two past clinical trials, we expect to be able to manage the danger of failure in clinical trials.
Dry eye syndrome is a prevalent multifactorial disorder that affects millions of individuals worldwide. DES is a disease in which the loss of tear film homeostasis leads to pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain a tiny active protein, thymosin beta 4 that occurs naturally in tears as well as other body fluids. RGN-259 eye drops have shown vast and multifunctional activity. Such operations underlie the effectiveness of RGN-259 eye drops seen to date in softening dry eye signs and symptoms. In addition, RGN-259 eye drops are secure and well-tolerated by nurses and minimal eye pain comparable to that of placebo was reported in both ARISE-1 and ARISE-2 patients.