HLB Therapeutics' RGN-259: What to Expect from the Upcoming Topline Results in November 2026?

(서울=뉴스1) 문대현 기자 = HLB Therapeutics announced on Wednesday that it has completed the last patient visit (LPLV) in the global Phase 3 clinical trial (SEER-2) for its neurotrophic keratitis treatment, RGN-259, through its U.S. subsidiary ReGenTree.

The completion of the LPLV marks the end of all patient-related clinical procedures. HLB Therapeutics aims to release the top-line results, which are the key findings, in November following data cleaning and statistical analysis.

SEER-2 is a clinical trial evaluating the corneal wound healing efficacy and safety of RGN-259 in patients with neurotrophic keratitis. The study encompasses 50 institutions, including 41 medical centers in the U.S. and 9 across three European countries: Italy, Spain, and Poland.

LPLV signifies the conclusion of the final dosing for the last patient and the completion of adverse reaction and safety assessments. With this milestone, the clinical trial has moved into the phase of organizing and analyzing the collected clinical data.

HLB Therapeutics has been systematically collecting and organizing data from institutions as patient enrollment concluded. The LPLV completion allows the company to expedite the remaining data cleaning and statistical analysis processes.

RGN-259 is a novel drug candidate in eye drop form, with Thymosin Beta 4, a regeneration-promoting protein, as its primary component. It's being developed to treat neurotrophic keratitis by leveraging mechanisms that enhance corneal wound healing and nerve regeneration.

Neurotrophic keratitis is a rare eye disorder characterized by corneal nerve damage, resulting in diminished corneal sensation and natural healing capacity. If left unchecked, it can lead to corneal epithelial defects, ulcers, perforations, and vision loss.

A spokesperson for HLB Therapeutics stated that the LPLV completion marks the end of all patient-related clinical procedures for SEER-2, bringing them to the final stage of result compilation. It's committed to efficiently processing the remaining data and analysis to unveil the top-line results in November.

HLB Therapeutics is currently focusing its growth strategy on cold chain operations and the development of novel treatments for rare diseases.

The company has successfully advanced RGN-259 to global Phase 3 trials for neurotrophic keratitis treatment. In 2026, it completed patient enrollment for the global Phase 3 trial (SEER-2) and concluded the last patient visit (LPLV) in August, now eagerly anticipating the announcement of top-line results.

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