European Clinical Trial for HLB Therapeutics’ RGN-259 Enters Final Analysis Stage

· HLB Therapeutics' European trial for NK treatment RGN-259 is in final analysis.

 

HLB Therapeutics' European trial for NK treatment RGN-259 is in final analysis. (Credit: HLB Therapeutics)

SEOUL, South Korea, March 27, 2025 (IT Times) – HLB Therapeutics has announced a significant milestone in the development of its novel treatment for neurotrophic keratitis (NK), RGN-259. The company revealed today that its European Phase 3 clinical trial, known as SEER-3, has entered its final analysis stage, with the last patient completing the dosing and follow-up observation period.

Conducted through its U.S. subsidiary, ReGenTree, the SEER-3 trial spanned 25 hospitals across Spain, Italy, Poland, and Germany. HLB Therapeutics confirmed on March 27 that the two-week follow-up for the final enrolled patient has officially concluded. The company is now preparing to lock the study data following a final review and will promptly initiate statistical analysis to expedite the release of topline results.

The European Phase 3 trial, which commenced in June 2023, demonstrated rapid progress, surpassing its initial patient enrollment target of 78 participants within just 20 months. This achievement allowed for the completion of recruitment four months ahead of the original schedule.

In parallel, HLB Therapeutics is also accelerating its U.S. clinical trial, SEER-2, by expanding its study sites into Europe. This strategic move follows approval from European regulatory authorities and is expected to significantly boost patient recruitment for the ongoing U.S.-based study.

RGN-259 is positioned as a potential game-changer in the NK treatment landscape, primarily due to its enhanced patient convenience compared to existing therapies. Currently, the only approved treatment globally for NK is Dompé's Oxervate. However, Oxervate requires an eight-week dosing regimen and involves a complex administration process, along with notable side effects. In contrast, RGN-259 offers a significantly shorter four-week treatment duration and is administered as a user-friendly single-use eye drop.

Given the substantial annual cost of approximately $120,000 associated with Oxervate and its dominant position in the U.S. market, where sales have exceeded $1 billion, RGN-259 has garnered considerable attention from global pharmaceutical companies. A U.S.-based valuation firm has estimated the potential market value of RGN-259 to range between $1.1 billion and $3.3 billion.

Ki-Hong Ahn, CEO of HLB Therapeutics, stated, "With the completion of dosing and follow-up for the final patient in our European Phase 3 trial, our focus now shifts to securing the topline data and conducting detailed analyses. If the results confirm the strong efficacy we anticipate, we will promptly advance licensing discussions with major global pharmaceutical entities."

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European Clinical Trial for HLB Therapeutics’ RGN-259 Enters Final Analysis Stage - IT타임스