GI Innovation to begin Phase 2 clinical trials for GI-301 in Japan

GI Innovation announced that the first patient dosing for the Phase 2 clinical trial of its allergy treatment candidate, GI-301 (lecigerccept), is scheduled to begin in Japan this October. The trial, which targets patients with chronic spontaneous urticaria (CSU), is being led by Maruho, the Japanese pharmaceutical company that holds the rights for development and commercialization in Japan.

Maruho executives recently visited GI Innovation’s Seongnam research center to discuss clinical strategies and development schedules. This milestone follows a 2023 licensing agreement valued at up to $221 million. Under the terms of the contract, GI Innovation is set to receive development milestones and royalties from product sales.

While Maruho manages the Japanese market, Yuhan Corporation holds the rights for global development outside of Japan and is currently conducting Phase 2 trials. The commencement of clinical activities in Japan is expected to accelerate the global commercialization timeline for the treatment.