First Patient Enrolled into U.S. Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259

Rhea-AI Summary

On April 13, 2023, RegeneRx Biopharmaceuticals (OTCQB: RGRX) announced the enrollment of the first patient in its Phase 3 clinical trial (SEER-2) for RGN-259, aimed at treating neurotrophic keratitis (NK). The trial, conducted by ReGenTree, involves over 70 NK patients and will focus on achieving complete corneal healing.

RGN-259, containing thymosin beta 4, has shown promise in previous studies, with significant efficacy in an earlier trial involving 18 patients. The company is conducting two simultaneous trials (SEER-2 and SEER-3) to expedite the approval process. The U.S. market for NK treatment includes about 20,000 patients annually. If successful, RGN-259 could present a substantial opportunity, especially considering the only existing treatment, Oxervate, is among the costliest in the U.S.

Positive

• Enrollment of the first patient in the Phase 3 trial (SEER-2) for RGN-259 demonstrates significant progress.
• Previous trials indicate potential efficacy for RGN-259 in treating neurotrophic keratitis.
• Simultaneous trials (SEER-2 and SEER-3) could accelerate the clinical development timeline.

Negative

• Regulatory hurdles exist, as two independent trials are required for market approval.
• Previous trials involved a small sample size (18 patients), raising concerns about the generalizability of results.

ROCKVILLE, Md., April 13, 2023 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has announced that on April 12, the first patient of the Phase 3 clinical trial (SEER-2) of RGN-259, a novel treatment for neurotrophic keratitis (NK), has been enrolled and begun treatment.  The product candidate is under development by ReGenTree, LLC, a U.S. joint venture between RegeneRx and HLB Therapeutics.

Clinical results in patients with NK treated with RGN-259 have previously demonstrated efficacy in a small number of patients (18) in the first phase 3 clinical trial (SEER-1), and two clinical trials are underway simultaneously in the United States and Europe based on these results.

Two independent clinical trials showing statistically significant safety and efficacy are required for marketing approval in the U.S. ReGenTree aims to significantly shorten the clinical development period by conducting the two phase 3 clinical trials (SEER-2 and SEER-3) at the same time, rather than sequentially.  The double-masked, placebo-controlled trials will be conducted by administering RGN-259 or placebo eye drops for four weeks to approximately 70 NK patients in each trial, with a primary endpoint of "complete corneal healing." Considering it is a rare disease, ReGenTree plans to recruit more than 30 clinical institutions in the U.S. to accelerate patient recruitment.

RGN-259, whose active ingredient is thymosin beta 4 (Tβ4), is a novel drug candidate that promotes cell migration, anti-inflammation, and wound healing. RGN-259 is formulated as a sterile, preservative-free eyedrop and has been shown to be safe and well-tolerated.

Neurotrophic keratitis offers a relatively large market opportunity as a rare disease with about 20,000 patients a year in the United States. Oxervate, from Dompé farmaceutici in Italy, is currently the only approved treatment for NK in the United States and is one of the most expensive pharmacy drugs in the U.S.

Regarding the clinical development of RGN-259 for dry eye syndrome, HLB Therapeutics noted that ReGenTree applied for SPA (Special Protocol Assessment) to the FDA in October of 2022, and has since been closely discussing clinical design, statistical analysis plans, and approval requirements with the FDA. SPA is a system whereby a sponsor consults with FDA in advance on clinical protocols and statistical analysis plans to increase the possibility of new drug approval. According to HLB, its strategy is to increase clinical design completeness and reduce uncertainty in the future as it believes RGN-259 will be an important clinical product for dry eye treatment given its past clinical results.

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. This press release has been prepared based on information provided primarily by HLB Therapeutics. 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 that any proposed clinical trials will be initiated, completed, or confirm previous results. 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, 2022, 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.

FAQ

What is the purpose of the Phase 3 clinical trial of RGN-259?

The Phase 3 trial aims to evaluate the efficacy and safety of RGN-259 for treating neurotrophic keratitis.

When did the first patient get enrolled in the RGN-259 clinical trial?

The first patient was enrolled on April 12, 2023.

How many patients will be involved in the RGN-259 clinical trials?

Approximately 70 patients will be recruited for each of the Phase 3 trials (SEER-2 and SEER-3).

What potential market impact does RGN-259 have?

RGN-259 could significantly impact the market for neurotrophic keratitis treatment, targeting approximately 20,000 patients annually in the U.S.

What are the expected outcomes of the RGN-259 trials?

The primary endpoint is complete corneal healing, which is crucial for gaining marketing approval in the U.S.