Japanese Maruho-led phase 2 clinical trial begins... Development milestone expected to be received based on first patient administration
Maruho’s key executives and staff visit Korea… Discuss Japanese clinical strategy and future development schedule
GI Innovation (358570) announced on the 7th that the first patient administration of the Japanese phase 2 clinical trial of GI-301 (Resigercept), an allergy treatment drug, is scheduled to begin in October. Once the first patient is administered, development milestones according to the contract will be received.
This clinical trial is led by Maruho, which holds the development and commercialization rights to GI-301 in Japan. Maruho submitted a phase 2 clinical trial plan (IND) for patients with chronic idiopathic urticaria to Japan's PMDA in May, and is preparing to administer the first patient in October.
On the 2nd, key executives and employees of Maruho visited the GI Innovation Seongnam Research Institute and discussed the Japanese phase 2 clinical trial strategy and future development schedule. Since signing a technology transfer agreement in 2023, the two companies have been discussing Japanese development strategies through regular joint development committees (JSDC).
[On the 2nd, key executives from Maruho visited GI Innovation Seongnam Research Institute and held a meeting and tour. /Source: Provided by GI Innovation]
At the time, GI Innovation transferred the development and commercialization rights to GI-301 in Japan to Maruho for up to $221 million (approximately 3,000 Billion Won at the time). According to the contract, milestones for each stage of development and commercialization and royalties based on product sales are received. This first patient administration is expected to be an opportunity for clinical development in Japan to enter the full-scale implementation phase.
GI-301 is an allergy treatment candidate developed by GI Innovation, and is also called by the development names YH35324 and M9010. Maruho holds development rights in Japan, and Yuhan Corporation holds development rights in global regions excluding Japan. Yuhan Corporation is also currently conducting phase 2 clinical trials of GI-301 (YH35324) for patients with chronic idiopathic urticaria (CSU).
Maruho, which was developed in Japan, is a pharmaceutical company specializing in dermatology that was founded in 1915. Approximately 95% of pharmaceutical sales come from the skin disease field, and the company has business capabilities ranging from research and development to clinical trials, manufacturing, and sales in various skin disease fields such as atopic dermatitis, acne, and psoriasis. Based on this commercialization infrastructure, we are also cooperating with global pharmaceutical companies.
Myeong-ho Jang, CEO of GI Innovation, said, “Global development is further expanding as GI-301 enters phase 2 clinical trials in Japan,” and added, “Based on close cooperation with Maruho, we will successfully conduct clinical trials in Japan and do our best to help GI-301 prove its competitiveness in the global allergy treatment market.”
