ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Pharmaceuticals (OTCBB:RGRX), and G-treeBNT Co. Ltd., a Korean biotech firm, jointly announced today that G-treeBNT is preparing to file an IND and sponsor a Phase III clinical trial with RGN-259 (a Thymosin Beta 4–based preservative-free eye drop) in patients with moderate to severe dry eye initially in South Korea, followed by Japan and Australia, with follow-on registrations in certain additional Asian and Pacific Rim countries if appropriate.
The proposed Phase lll trial is based on data generated in a 72-patient, double-masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, Inc., an ophthalmic CRO in the U.S. and Japan, as well as data generated in a recently completed 9-patient physician-sponsored, double-masked, placebo-controlled clinical trial in patients with severe dry-eye syndrome, both conducted in the U.S. Both Phase II trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort.
In the 72-patient trial in the U.S., patients were diagnosed with moderate dry eye, treated with RGN-259 or placebo four times daily for 28 days, and evaluated using Ora’s proprietary controlled adverse environment (CAE) model. RGN-259 was found to be safe and well-tolerated and patients had statistically significant improvements in several signs and symptoms of dry eye at several time points during the study, offering protective effects when patients were “challenged” in the CAE model.
In a 9-patient severe dry eye study conducted at the Kresge Eye Institute in Detroit, RGN-259 was found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment, which is consistent with the potentially protective effects observed in the Ora study.
The reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the cornea while improvement in ocular discomfort reflects how the patient’s eye feels. The effects of RGN-259 were seen relatively quickly and there were no adverse events associated with the drug in Phase II. These results reflect the known mechanisms of action of RGN-259.
“With two RGN-259 Phase II dry eye trials completed in the U.S., we are very pleased that our strategic partner, G-treeBNT, intends to move into Phase III,” stated J.J. Finkelstein, president & chief executive officer of RegeneRx Biopharmaceuticals. “We have been working closely with G-treeBNT on the development of RGN-259 and a successful Phase III clinical trial in Asia would be a critical milestone as G-treeBNT has the rights to commercialize RGN-259 in 28 countries in Asia and Pacific Rim including South Korea, Japan and Australia.”
“We have decided to initially file an IND for a Phase III clinical trial with RGN-259 in South Korea, followed by a similar strategy in Japan and Australia. If successful, this will facilitate the commercialization of RGN-259 in other countries in Asia and the Pacific Rim that are covered by our strategic partnership with RegeneRx. Our target is to submit an IND for Phase III within 2014 in order to achieve the first patient recruitment before the end of the first quarter of 2015,” stated Won S. Yang, president and chief executive officer of G-treeBNT.
About RegeneRx Pharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the EU, and has an extensive worldwide patent portfolio covering its products. Recently, RGN-259, the Company’s ophthalmic drug candidate has been designated as an orphan drug for the treatment of neurotrophic keratopathy, which is the primary focus of RegeneRx’s clinical development efforts in the U.S. For additional information about RegeneRx please visit www.regenerx.com
About G-treeBNT Co. Ltd.
G-treeBNT (formerly “Digital Aria”) is one of the major players in the IT software industry in Korea since 2000, and based on a foundation of distinguished success achieved in the IT software market, G-treeBNT made a key strategic decision in 2013 to participate in the innovative biopharmaceutical business through carefully selected strategic alliances with distinguished leading bio-venture companies in the US and EU. The strategic alliance with RegeneRx is the first strategic investment in its progressive challenge to create a multi-national biopharmaceutical company. Currently the company is developing an innovative pipeline for dry eye syndrome in 28 Asian and Pacific Rim countries by preparing for Phase III clinical trials while developing a second product in the U.S. for the orphan indication, Epidermolysis Bullosa.
About RGN-259 for the Treatment of Dry Eye Syndrome
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on two Phase II clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The results from these trials reflect RGN-259’s mechanisms of action, appear to support the “protective” effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials.
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, such as the filing of a Phase III IND by G-treeBNT or development of RGN-259 in Asia, involves speculation and uncertainties that may or may not prove to be accurate and may be materially different from any results or timing implied by such forward-looking statements. Please view these and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2013, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. 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, including information provided by G-treeBNT, except as required by applicable law.