Press Release (ePRNews.com) - PRINCETON, N.J. - Oct 31, 2017 - ReGenTree, LLC, a joint venture between GtreeBNT and RegeneRx, announced today that the Phase 3 clinical trial (ARISE-2) of RGN-259 for the treatment of dry eye has been completed. The ARISE-2 trial investigated the safety and efficacy of RGN-259 compared to placebo for the treatment of the signs and symptoms of dry eye syndrome in 601 patients.
The ARISE-2 study, which was conducted together with Ora, Inc., demonstrated a number of statistically significant improvements in both signs and symptoms of dry eye syndrome with 0.1% RGN-259 versus placebo, while showing excellent safety, comfort and tolerability profiles. The ocular discomfort symptom showed a statistically significant reduction in the RGN-259-treated group at day 15 as compared to placebo (p=0.0149) in the change from baseline. For sign, RGN-259 also improved the dry eye patients’ ability to withstand an exacerbated condition in a patient subgroup with both compromised corneal fluorescein staining and Schirmer’s test at baseline. In this population, RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). RGN-259 confirmed its global effects on dry eye syndrome and fast onset in multiple sign and symptom efficacies with no safety issues in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2 was not successful in duplicating the results of ARISE-1 where the study population was limited and less diversified.
Won S. Yang, President & CEO of ReGenTree, stated, “We are very excited with the ARISE-2 results, which show RGN-259’s important additional efficacies lacking in approved treatments, such as very fast onset and multiple global effects in both signs and symptoms of dry eye syndrome. I believe these two studies, ARISE-1 and ARISE-2 with efficacy of Tβ4 in both signs and symptoms, will continue building a strong foundation of its strengths when considered with the totality of the data set. ReGenTree plans to proceed with a development plan for the next step through a meeting with the FDA based on the results of ARISE-2 trial. We are optimistic that the results from ARISE-2 will accelerate discussions with potential investors interested in reaching a global deal for the development and marketing of RGN-259.”
About ReGenTree, LLC
ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the USA and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has completed two Phase 3 studies in the USA for dry eye which are ARISE-1 (Phase 2/3) and ARISE-2 (Phase 3). In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.com.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any current or future clinical trials will result in approved products or future value. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
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