TOKYO, Jul 01 (Pulse News Wire) – RIBOMIC Inc. (4591.T) launched a domestic phase III clinical trial for umedaptanib pegol, aimed at treating children aged two to 14 with achondroplasia.
The trial design includes evaluating efficacy over 52 weeks without a placebo control group due to ethical concerns and practical considerations. Key evaluation metrics focus on annual height velocity changes and safety assessments. The study plans to enroll up to 16 patients across multiple medical institutions, with treatment expected to conclude by April 2028.
Safety measures are stringent, incorporating initial hospital-based observation, regular monitoring, and independent safety review committees. Previous trials showed no significant adverse reactions, but increased vigilance is applied for younger subjects. The trial's detailed design outlines inclusion and exclusion criteria, assessment methods, dosing schedules, and safety management procedures.
There will be no impact on the fiscal year 2027 earnings forecast.
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