HLB Therapeutics Expands U.S. NK Therapy Clinical Trial to Europe

HLB Therapeutics announced on September 30 that it will expand subject recruitment for the ongoing U.S. Phase 3 clinical trial (SEER-2) conducted by its U.S. subsidiary, Regentree, to Europe. This decision is part of the company's strategy to accelerate the topline results as much as possible.

Chief Executive Officer Ahn Kihong and other key executives recently completed meetings with principal investigators (PIs) from major European clinical sites who will participate in the U.S. trial's expansion into Europe. They also discussed the analysis of the European clinical trial (SEER-3) results. It was confirmed that patient recruitment can begin starting next month.

During the face-to-face meetings with the principal investigators of the major clinical sites, feedback was provided regarding the reasons why statistical significance was not achieved in SEER-3. The company explained that in SEER-2, they held in-depth discussions on specific measures to prevent the recurrence of the same outcome. The European clinicians also expressed regret that statistical significance was not achieved in SEER-3, but stated their intention to actively cooperate with the company's efforts to ensure the success of the SEER-2 trial.

HLB Therapeutics is also scheduled to hold meetings with global partners at the American Academy of Ophthalmology (AAO) conference, which will be held in Orlando, United States, from October 18 to 20.

During these meetings, the company shared an analysis of the European clinical trial (SEER-3) results, updates and timelines for the U.S. SEER-2 clinical trial, and non-clinical study results regarding the corneal nerve regeneration efficacy of RGN-259. The agenda also included plans to expand indications to another rare ophthalmic disease, Limbal Stem Cell Deficiency (LSCD), using RGN-259. Through these efforts, the company aims to further strengthen its collaborative relationships.