HLB Therapeutics Begins Phase 3 Dosing of Neurotrophic Keratitis Treatment in the US

HLB Therapeutics announced on the 13th that it has begun dosing for the Phase 3 clinical trial in the United States of 'RGN-259,' which is being developed as a treatment for neurotrophic keratitis (NK).

Ahn Ki-hong, CEO of HLB Therapeutics
[Photo by HLB Therapeutics]

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RGN-259, developed through its U.S. subsidiary Regentry, contains the active ingredient thymosin beta 4 (Tβ4), which promotes cell migration and has various mechanisms specialized in anti-inflammation and wound healing, raising expectations for its potential as a treatment for ophthalmic diseases. HLB Therapeutics is conducting clinical trials for dry eye disease (DED) and NK using RGN-259 developed as an eye drop formulation.

The Phase 3 trials are currently being conducted simultaneously in the U.S. (SEER-2) and Europe (SEER-3) with a slight time difference. Ki-Hong Ahn, CEO of HLB Therapeutics, previously stated, "New drug approvals for ophthalmic diseases require verification of repeated treatment effects," and added, "We plan to start in the U.S. first and complete all dosing within this year." Since the U.S. Food and Drug Administration (FDA) typically requires results from two Phase 3 trials for approval, the company aims to significantly shorten the development period by conducting the two trials sequentially but concurrently.

The U.S. Phase 3 trial will involve dosing 70 NK patients with RGN-259 for four weeks. The number of clinical sites will be expanded to over 30 to accelerate patient recruitment.

Although NK is a rare disease, it has a relatively large market size with about 20,000 patients occurring annually in the U.S. alone. Currently, 'Oxervate' is the only treatment prescribed in the U.S., but its monthly cost exceeds $50,000 (approximately 66.28 million KRW), imposing a significant financial burden on patients. In Europe, although approved, actual usage remains limited.

An HLB Therapeutics representative stated, "The primary efficacy endpoint for NK is clearly defined as 'complete healing,'" and added, "Since efficacy was already confirmed in the first clinical trial, we will focus all corporate capabilities on the prompt progress of the U.S. Phase 3 trial and the imminent start of the European Phase 3 trial."

HLB Therapeutics is also developing a treatment for dry eye disease. For the fourth Phase 3 trial, 'ARISE-4,' the company applied for a Special Protocol Assessment (SPA) with the FDA in October last year and is currently discussing clinical design and statistical analysis plans with the FDA. SPA is a process where the developer consults with the FDA in advance on clinical procedures and statistical analysis plans, allowing the FDA to participate from the clinical design stage, which can increase the likelihood of new drug approval.

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