Phase III ARISE-3 trial of RGN 259 fails to meet endpoint in dry eye syndrome.- RegeneRx Biopharma

RegeneRx Biopharmaceuticals announced that the ARISE-3 Phase III clinical trial evaluating RGN 259 (timbetasin) 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 III 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 III trials. Comprehensive results will be released when all the data analyses are completed.