Phase 2 trial led by Japan’s Maruho; development milestone payment expected following first patient dosing.
Maruho executives visit South Korea to discuss clinical strategy and development timelines for the Japanese market.
GI Innovation (358570) announced on the 7th that the first patient dosing for its allergy therapeutic, GI-301 (lesigersept), in a Japanese Phase 2 clinical trial is scheduled for October. The company is set to receive a development milestone payment as stipulated in the licensing agreement once the first patient is treated.
The clinical trial is being spearheaded by Maruho, which holds the development and commercialization rights for GI-301 in Japan. Maruho submitted its Investigational New Drug (IND) application for a Phase 2 study targeting patients with chronic spontaneous urticaria to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in May and is currently preparing for the inaugural dosing slated for October.
On the 2nd, senior executives from Maruho visited GI Innovation’s research center in Seongnam to discuss the Phase 2 clinical strategy and future development milestones. Since signing the technology transfer agreement in 2023, the two companies have held regular Joint Steering and Development Committee (JSDC) meetings to align on their development strategy for the Japanese market.
[Senior executives from Maruho visited GI Innovation’s Seongnam research facility on the 2nd for meetings and a site tour. / Source: GI Innovation]
Under the terms of the agreement, GI Innovation licensed the development and commercialization rights for GI-301 to Maruho for up to $221 million (approximately KRW 300 billion at the time of the deal). The contract includes milestone payments tied to development and commercialization stages, as well as royalties on future product sales. The first patient dosing marks the transition of the Japanese clinical development program into the active execution phase.
GI-301 is an allergy treatment candidate developed by GI Innovation, also known by the development codes YH35324 and M9010. While Maruho holds the rights for Japan, Yuhan Corporation retains development rights for the rest of the world. Yuhan is currently conducting its own Phase 2 clinical trials for GI-301 (YH35324) in patients with chronic spontaneous urticaria (CSU).
Maruho, the partner overseeing the Japanese development, is a dermatology-focused pharmaceutical company established in 1915. Approximately 95% of its pharmaceutical sales are derived from dermatological conditions, with end-to-end capabilities ranging from R&D and clinical trials to manufacturing and sales in areas such as atopic dermatitis, acne, and psoriasis. Leveraging this commercial infrastructure, the company maintains robust partnerships with global pharmaceutical firms.
“With GI-301 now entering full-scale Phase 2 trials in Japan, our global development footprint is significantly expanding,” said Myung-Ho Jang, CEO of GI Innovation. “We will work closely with Maruho to ensure the success of the Japanese clinical trials and do our utmost to prove the competitiveness of GI-301 in the global allergy treatment market.”
