HLB Therapeutics Completes Global Phase 3 Patient Enrollment for RGN-259

HLB Therapeutics has completed patient enrollment for the global Phase 3 clinical trial (SEER-2) of 'RGN-259,' a treatment for neurotrophic keratitis (NK) developed by its U.S. subsidiary RegeneRx.

According to HLB Therapeutics on July 20, RGN-259 is an ophthalmic novel drug candidate being developed based on Thymosin β4. It is designed to protect the cornea and promote wound healing. RegeneRx is conducting the global Phase 3 clinical trial to evaluate the efficacy and safety of RGN-259 in patients with neurotrophic keratitis in the United States and Europe.

With the completion of patient enrollment, the company plans to proceed with the remaining administrations and follow-up for the enrolled subjects in accordance with the clinical trial protocol. Subsequently, procedures to ensure the accuracy and consistency of the clinical data, including data cleaning, database lock, and statistical analysis, will be carried out sequentially. Considering the time required for subsequent clinical steps and data organization, the company expects the topline results to be available within approximately two to three months after the last subject's final visit. The results will be released as soon as they are obtained.

A representative from HLB Therapeutics stated, "We have met the protocol requirements necessary for generating the clinical results," and added, "We will diligently and promptly carry out the remaining steps, including administration, follow-up, and data analysis, to validate the new drug value of RGN-259 and maximize potential for global partnerships."

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