HLB Therapeutics announced on the 24th that it had not secured statistical efficacy in the European phase 3 clinical trial (SEER-3) for the neurotrophic keratitis treatment 'RGN-259', conducted by its U.S. subsidiary, Regentree.
Regentree received results of the primary (topline) endpoint from the contract research organization (CRO) that performed the European phase 3 trial (SEER-3) the previous day and noted that no statistically significant difference was observed in the cure rates between the RGN-259 treatment group and the placebo group at the 4-week mark, the primary evaluation variable.
The company stated that while a significant number of cured patients were observed in the RGN-259 treatment group, the unexpected placebo effect in the placebo group led to somewhat puzzling results.
Regentree plans to conduct a thorough analysis to determine the cause of the results exceeding the placebo.
The company emphasized that although it did not achieve the expected results in the European trial, negotiations with global pharmaceutical companies would continue, as the phase 3 trial for RGN-259 is currently underway in the United States.
Generally, clinical trials for eye diseases are complex in design and are carried out in two phases. Regentree has been accelerating development by conducting phase 3 trials concurrently in the U.S. and Europe, with patient recruitment in the U.S. phase 3 trial aiming for completion by the end of this year.
Ahn Gi-hong, CEO of HLB Therapeutics, said, 'We will precisely analyze the results of all evaluation variables to closely identify the causes and swiftly reorganize the overall clinical strategy based on this.' He noted, 'The company will focus all its resources on the ongoing U.S. phase 3 trial to achieve successful results more quickly.'