[E-Daily Reporter KIM SAE-MI ] HLB Therapeutics(115450)has completed patient enrollment for the global Phase 3 clinical trial of “RGN-259,” which is being developed as a treatment for neurotrophic keratitis (NK). Following data collation and statistical analysis, the company plans to release topline results this November.

HLB Therapeutics announced on the 26th that its U.S. subsidiary, ReGenTree, has completed the last patient visit (LPLV) for the global Phase 3 clinical trial (SEER-2) of RGN-259.

LPLV refers to the point at which the final visit and safety assessment for the last clinical trial participant are completed. Accordingly, all patient-related procedures for the SEER-2 trial have concluded, and the next steps—including data cleaning, database lock (DB Lock), and statistical analysis—will now proceed.

Regentree has been conducting data collection and cleaning, prioritizing clinical sites where patient enrollment was completed first. Based on the data organization and analysis schedule provided by the contract research organization (CRO), the company aims to announce topline results in November.

SEER-2 is a randomized, double-blind, placebo-controlled global Phase 3 clinical trial evaluating the corneal wound-healing efficacy and safety of RGN-259 in patients with neurotrophic keratitis. It was conducted at a total of 50 medical institutions, including 41 hospitals in the United States and 9 hospitals in three European countries—Italy, Spain, and Poland.

HLB Therapeutics completed patient enrollment for SEER-2 last July. At that time, the company determined that it could meet the protocol requirements necessary to derive clinical results without recruiting additional patients. The company had previously estimated that it would take approximately 2 to 3 months from the final visit of the last patient to the release of top-line results.

RGN-259 is a new drug candidate in the form of eye drops whose active ingredient is thymosin beta-4, a protein that promotes regeneration. It is being developed as a treatment for neurotrophic keratitis based on its mechanism of action, which promotes corneal wound healing and nerve regeneration. It has been designated as an orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of neurotrophic keratitis.

RGN-259 is a pipeline project that HLB Therapeutics has been developing for dry eye syndrome since its days as Ztree B&T, having conducted the ARISE-1 (Phase 2b/3) and ARISE-2 and 3 (Phase 3) clinical trials. Although 700 patients participated in ARISE-3, the trial failed to meet its primary endpoint; however, signs of efficacy were observed in some secondary endpoints and subgroup analyses. The company is currently preparing for ARISE-4, an additional Phase 3 clinical trial for the dry eye indication.

Nor is the current SEER-2 the first Phase 3 clinical trial for neurotrophic keratitis. The previously conducted SEER-1 trial had originally planned to enroll 46 patients but was terminated early with only 18 patients due to issues such as patient recruitment. At that time, after 4 weeks of treatment, corneal wounds were fully healed in 6 out of 10 patients (60%) in the RGN-259 group and 1 out of 8 patients (12.5%) in the placebo group. The primary endpoint did not meet statistical significance (P=0.0656). Consequently, Regentree has been pursuing the SEER-2 and SEER-3 Phase 3 clinical trials to further validate the drug’s efficacy in neurotrophic keratitis.

Neurotrophic keratopathy is a rare degenerative eye disease characterized by damage to the corneal nerves, resulting in impaired corneal sensation and a reduced ability for natural healing. As the disease progresses, it can lead to persistent corneal epithelial defects or ulcers; in severe cases, it may result in corneal perforation or vision loss.

An HLB Therapeutics spokesperson stated, “With the completion of this LPLV, we have concluded all patient-related clinical procedures for SEER-2 and have entered the final stage of deriving results,” adding, “We plan to review and analyze the remaining data to confirm the topline results.”