RegeneRx Biopharmaceuticals, Inc. Reports Topline Results of ARISE-3 Dry Eye Trial
March 18, 2021 at 06:51 am EDT
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RegeneRx Biopharmaceuticals, Inc. announced that the ARISE-3 Phase 3 clinical trial evaluating RGN-259 eyedrops for the treatment of dry eye syndrome did not meet its primary outcome measures. However, efficacy was seen in the improvement of ocular grittiness, one of the pre-specified secondary symptom endpoints in the trial. The statistically significant improvement was seen at one and two weeks after treatment, and post-exposure in a controlled adverse environment after two weeks of treatment with RGN-259 compared to placebo (p=0.0104, 0.0307, and 0.0046, respectively). RGN-259 continued to demonstrate safety in treatment of dry eye syndrome consistent with previous clinical trials. In the ARISE-3 trial, there were no serious adverse events with only mild to moderate adverse events in both the active and placebo arms. The most common ophthalmic adverse event was mild ocular pain upon instillation (RGN-259 6.6% vs. placebo 4.6%). Based on preliminary post-hoc analyses by GtreeBNT using all of the patients in the three phase 3 trials, the population compromised by a corneal sum fluorescein staining score showed significant improvement in sign efficacy parameters such as fluorescein staining scores in the central, corneal sum, conjunctival sum, and total sum after two weeks of treatment. Additional analyses are being conducted to define efficacies in various sign and symptom parameters using the pooled data of the three phase 3 trials. Comprehensive results will be released when all the data analyses are completed. Data analysis is expected to be focused on the fast on-set and multifunctional effects of RGN-259 that were shown in all three clinical trials. Based on these results, GtreeBNT and RegeneRx will explore the prospects of a pre-BLA meeting with the FDA using the pooled data or discuss a detailed plan for additional clinical studies, if needed.
RegeneRx Biopharmaceuticals, Inc. (RegeneRx) is a biopharmaceutical company. The RegeneRx is focused on the development of a therapeutic peptide Thymosin beta 4(Tb4) for tissue and organ protection, repair, and regeneration. RegeneRx operates in the development and marketing of Tb4, an amino acid peptide. Tb4 is a synthetic copy of a naturally occurring 43-amino acid peptid originally isolated from bovine thymus glands. The Company's product candidates in clinical development includes RGN-259, RGN-352, and RGN-137. The Company's RGN -259 is a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology. RGN-352 is an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases. Its RGN-137 is a topical gel for dermal wounds and reduction of scar tissue.