RegeneRx Releases Letter to Stockholders

ROCKVILLE, Md., May 17, 2016 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today released the following letter to stockholders regarding its recent Phase 2/3 dry eye clinical trial: Dear Stockholder: We are very pleased to report to you in more detail on our recently completed Phase 2/3 dry eye clinical trial. Overall the results were very positive and accomplished much of what we and our partner, GtreeBNT, set out to accomplish. Results from clinical trials can be complicated for the layperson to fully understand so the purpose of this letter is to explain our achievements in a more stockholder-friendly manner. The key messages are that while we did not meet our specific primary outcome measures, (1) we did achieve numerous important and statistically significant efficacy endpoints, (2) we saw a dose response that enables us to identify the lowest and best dose, and (3) we demonstrated reproducibility in improving symptoms of dry eye that confirmed previous Phase 2 clinical results. These are all important to determining our next clinical steps. The clinical trial was sponsored by ReGenTree, LLC, a U.S. joint venture between RegeneRx and GtreeBNT to develop RGN-259 eye drops for the treatment of dry eye in the U.S. and Canada. The Phase 2/3 trial was a double-masked, placebo-controlled trial in 317 patients with moderate to severe dry eye syndrome who were divided into three groups of patients: high dose (0.1% Tβ4), low dose (0.05% Tβ4), and placebo (no Tβ4). Each group had approximately 105 patients. The patients used RGN-259 four times daily for 28 days. The clinical trial was managed by Ora Inc., the world's leading full-service ophthalmic contract research organization (CRO) and product development firm with offices in the United States, the United Kingdom and Japan. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to help bring their new products from concept to market. The following are the key results from the trial, most of which represent important statistically significant benefits in favor of RGN-259 compared to placebo, as well as offer other insights into the performance of RGN-259, which we believe is of high interest to prospective pharma companies/partners: We confirmed an important efficacy endpoint from our prior Phase 2a clinical trial. We saw confirmation between our first Phase 2a trial and our Phase 2/3 trial at an important pre-specified endpoint at Day 29 (Visit 5), which was the day after the last day of dosing with RGN-259. The "symptom" endpoint was the patient's ocular discomfort at Time 0 in the controlled adverse environment (CAE) model compared to 75 minutes and 90 minutes in the CAE. Thus, we had two independent studies that saw statistically significant benefits of RGN-259 for ocular discomfort during CAE challenge when their dry eye symptoms were stressed. We believe that these two independent studies demonstrate reproducible results, an important factor as we move forward with clinical development. This endpoint is similar to the primary symptom endpoint designated in the protocol that was designed to assess ocular discomfort pre-CAE compared to discomfort post-CAE.  We achieved a dose response in the trial. A dose response assessment comparing 0.05% (low dose) to 0.1% (high dose) was an important component of the trial and was the purpose of having two active groups in addition to placebo. The 0.1% Tβ4 concentration showed a significantly stronger response in most cases than the 0.05% dose group and helps answer the question of the lowest and best active dose for regulatory and marketing purposes, which the FDA prefers for obvious reasons.  We demonstrated quick relief of certain dry eye signs and symptoms and a statistically significant improvement in efficacy that increased with longer administration of RGN-259. We saw improvement trends at 2 weeks, which we believe are faster than any product on the market or under development. These improvement trends continued and became statistically significant at 4 weeks. This indicates that RGN-259's effects on dry eye improve over time, even within a relatively short 28-day period of administration. We believe this activity is one of several advantages that will set us apart from other products on the market or under development and should be of significant interest to industry. We also saw a statistically significant correlation between severity of dry eye and effect of RGN-259, i.e., the more severe the dry eye, the better RGN-259's effect. Patients were assessed for their Tear Film Breakup Time (TFBUT).  TFBUT is an important marker that often correlates with the severity of corneal damage and dry eye. The longer the TFBUT the more stable the tear film.  Patients with short or poor TFBUT may have greater problems with corneal disruption and healing as evidenced by fluorescein staining. In patients having short TFBUT, we demonstrated significant improvement with RGN-259 that indicates it had an effect in more severe dry eye patients. This also correlates with what Dr. Gabriel Sosne reported with RGN-259 in his 9-patient trial in severe dry eye. (Cornea; Volume 34, Number 5, May 2015) We observed a rapid increase in tear production in patients using RGN-259 that was statistically significant. Improvement of tear production tends to occur only with longer dosing. To date, the only FDA-approved drug for dry eye does not induce tear production as quickly at 2-4 weeks as RGN-259 does. Rapid increase in tear production is not typically or randomly seen in dry eye trials, therefore, we believe the statistically significant results in the Schirmer's Test for tear production was a real effect. The big jump in the Schirmer's Test with RGN-259 may be explained by RGN-259's anti-inflammatory properties leading to reduction of inflammation in the lacrimal glands that produce tears, therefore improving tear production. Patients reported more comfort with our product than has been reported with other products either on the market or under development. RGN-259 eye drops were very comfortable to use. Below is a chart that compares patient responses to various products for dry eye: Product Comfort level      1 = best Symptoms RGN-259 1-2 None Currently approved product 5-7 Burning and stinging Current product under development 5-7 Burning, stinging, dysgeusia (foul taste in mouth)

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