ARISE-3 Study, the Phase 3 Clinical Trial of the New Drug RGN-259 for the Treatment of Dry Eye Syndrome is Initiated by ReGenTree

PRINCETON, N.J., Feb. 11, 2019 /PRNewswire/ -- ReGenTree, LLC (the Company), a joint venture between GtreeBNT and RegeneRx Biopharmaceuticals, announced today that it has executed an agreement with Ora, Inc., located in Andover, Massachusetts, for the initiation of ARISE-3 to study the Company's new drug RGN-259 for the treatment of dry eye syndrome. ARISE-3 is a randomized, double masked, placebo controlled phase 3 clinical trial which is based entirely on the results of the company's previous clinical trials, ARISE-1 and ARISE-2. "A total of 700 patients will be enrolled into the trial and the Company expects the treatment will be completed in the first half of 2020," stated officials at the Company.

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 both 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 U.S. for dry eye which are ARISE-1 (Phase 2b/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.

About Ora, Inc.
Ora is a full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom, Australia and Japan. Over the past 40 years, Ora has proudly helped clients earn 46 product approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven across thousands of global projects. For more information, please visit www.oraclinical.com

Forward-Looking Statements

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. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. 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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SOURCE ReGenTree, LLC