HLB Therapeutics Completes Global Phase 3 for 'RGN-259'... Topline Results in November
Last Patient Visit Completed at 50 Medical Institutions in the U.S. and Europe
Topline Results Targeted for November After Data Cleaning and Statistical Analysis
HLB Therapeutics announced on August 26 that it has completed the Last Patient Last Visit (LPLV) for the global Phase 3 clinical trial (SEER-2) of 'RGN-259,' a treatment for neurotrophic keratitis (NK), which was conducted through its U.S. subsidiary ReGenTree.
LPLV refers to the point at which the final adverse event and safety assessments are completed for the last patient, signaling the end of patient-related clinical procedures and the transition to the data analysis stage.
SEER-2 is a clinical trial designed to evaluate the corneal wound healing effect and safety of RGN-259 in patients with neurotrophic keratitis. The trial was conducted at a total of 50 medical institutions, including 41 hospitals in the United States, as well as 9 hospitals in 3 European countries: Italy, Spain, and Poland.
ReGenTree has been sequentially collecting and cleaning data from institutions where patient enrollment was completed. With the completion of LPLV, the company plans to accelerate the remaining data organization and statistical analysis, aiming to release topline results in November.
RGN-259 is a new drug candidate in the form of eye drops, with thymosin beta 4, a protein that promotes regeneration, as its main component. It is being developed as a treatment for neurotrophic keratitis based on a mechanism that promotes corneal wound healing and nerve regeneration.
Neurotrophic keratitis is a rare ophthalmic disease in which damage to corneal nerves leads to reduced corneal sensation and diminished natural healing ability. As the disease progresses, corneal epithelial defects and ulcers can occur, and in severe cases, it may lead to corneal perforation and vision loss.
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A representative from HLB Therapeutics stated, "With the completion of LPLV, we have concluded all patient-related clinical procedures for SEER-2 and entered the final stage toward result generation," adding, "We will do our best to carry out the remaining data organization and analysis without delays so that topline results can be confirmed quickly."
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