Publication of RGN-259 Phase 3 Clinical Trial Results in Patients with Neurotrophic Keratopathy
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced the publication of phase 3 clinical trial results demonstrating the safety and efficacy of RGN-259 eyedrops for treating Neurotrophic Keratopathy. The trial showed complete healing in 6 out of 10 patients treated with RGN-259, while only 1 out of 8 in the placebo group healed. The product aims to improve ocular comfort and has a favorable safety profile with no significant adverse effects reported. This development enhances the prospects for ongoing trials in the U.S. and EU, expected to commence this month.
- Phase 3 trial showed complete healing in 6 of 10 patients treated with RGN-259.
- Significant improvements in ocular discomfort and dryness reported.
- No significant adverse effects observed, indicating a favorable safety profile.
- Publication in a peer-reviewed journal strengthens the credibility of the trial results.
- Upcoming phase 3 trials in the U.S. and EU are set to start this month.
- None.
ROCKVILLE, Md., Jan. 3, 2023 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting today a new scientific publication describing the safety and efficacy of RGN-259 eyedrops in a phase 3 clinical trial in patients with Neurotrophic Keratopathy (NK). The product candidate is being developed by ReGenTree, LLC, a U.S. joint venture between RegeneRx Biopharmaceuticals and HLB Therapeutics.
The study determined the efficacy and safety of RGN-259 in promoting the healing of persistent epithelial defects in patients with Stage 2 and Stage 3 NK. Complete healing occurred after 4 weeks in 6 of 10 RGN-259-treated subjects and 1 of 8 placebo-treated subjects, indicating a strong efficacy trend. Additional statistically significant healing was observed at day 43, two weeks after cessation of treatment, with no recurrent defects.
RGN-259-treated subjects had significant improvements at multiple time points in ocular discomfort, foreign body sensation, and dryness, which were not seen in the placebo group. No significant adverse effects were observed.
"While these results have been previously reported, it is important that the final data were published in a peer-reviewed scientific journal. Based on the results of this trial, we look forward to the first of two phase 3 trials in the U.S. and EU with the first patient expected to be entered later this month. The trials are being sponsored by our JV partner, ReGenTree," stated Dr. Allan Goldstein, Chairman and Chief Scientific Officer of RegeneRx.
The publication is entitled,
RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy. To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications. Thymosin beta 4, is the active pharmaceutical ingredient of RGN-259 that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties.
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. Forward-looking statements in this press release include but are not limited to statements from us, our partners, or within research published by the Company or unaffiliated third parties. There can be no assurance of the timing of any clinical trials or that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view 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, 2021, 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, except as required by applicable law.
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SOURCE RegeneRx Biopharmaceuticals, Inc.
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