RegeneRx: Phase 3 ARISE-3 trial 'progressing smoothly' according to plan
RegeneRx Biopharmaceuticals announced that GtreeBNT, its Korean partner in the U.S. development of RGN-259 for the treatment of dry eye disease, issued an update on the U.S. phase 3 clinical trial. The following translation was provided to RegeneRx by GtreeBNT, with certain clarifications made by RegeneRx: "The ongoing clinical trial of dry eye -- ARISE-3 -- is progressing smoothly according to the plan. In the second and third quarters of 2019, we made significant effort to select appropriate clinical study sites, and we have identified and selected around 15 eye hospitals as study sites and started clinical trials sequentially. In addition, by actively utilizing databases held by hospitals to select patients that meet the criteria for recruiting clinicians, and by proactively asking questions to better identify patient status learned from ARISE-1 and ARISE-2, we are becoming more efficient and accurate with patient screening in this ARISE-3 clinical trial. In addition, since we are focusing more fully on clinical management based on know-how that we have learned from the two previous clinical trials, we expect that we will be able to control the risk of clinical trial failure. Furthermore, in the FDA approval process for new dry eye products, we believe that all data from previous trials as well as this ongoing study will be analyzed and included in the Data Totality concept. When you combine the results of two already completed clinical studies and the data from the currently ongoing ARISE-3 clinical trial, it is expected that all three Phase 3 studies will show the same consistent effect and trend. We also expect the pace of patient recruitment will be accelerated in the fall and winter, when the dry eye season comes, so we believe it will be easier to achieve our goal of completing the treatment of patients by the end of 2nd quarter of 2020. In the future, we will be able to talk more often about our ARISE-3 situations in order to address the interests of shareholders and related parties."