GI Innovation said Wednesday that the first patient in a Japanese phase 2 trial of its allergy treatment candidate GI-301 is scheduled to receive the drug this month.
Under a licensing agreement with Maruho signed in 2023, GI Innovation transferred Japanese development and commercialization rights for GI-301 to Maruho in a deal worth up to 300 billion won ($221 million) at the time.
The Korean biotech is entitled to milestone payments tied to development and commercialization, along with royalties on product sales.
Founded in 1915, Japanese drugmaker Maruho specializes in dermatology, which accounts for about 95 percent of its pharmaceutical sales. The company handles research, clinical development, manufacturing, and sales of treatments for conditions including atopic dermatitis, acne, and psoriasis.
The phase 2 study will evaluate GI-301, also known as resigercept, in patients with chronic spontaneous urticaria. Maruho submitted an investigational new drug application for the trial to Japan’s Pharmaceuticals and Medical Devices Agency in May. Its executives visited GI Innovation’s research center in Seongnam, Gyeonggi Province, on Friday to discuss the clinical plan and development schedule.
Since signing the agreement, the two companies have coordinated the Japanese development program through regular joint steering development committee meetings.
“GI-301 is entering phase 2 development in Japan,” GI Innovation CEO Jang Myoung Ho said, adding that the company plans to work closely with Maruho on the Japanese trial and subsequent development.
yejinlim@heraldcorp.com
