[Edaily Reporter KIM SAE-MI ] The Phase 2 clinical trial in Japan for GI Innovation Inc.(358570)’s new allergy drug candidate “GI-301” (resigercet) is set to begin in earnest. Once the first patient receives the drug this month, GI Innovation Inc. will receive a development milestone payment from its Japanese partner, Maruho.

GI Innovation Inc. announced on the 7th that the first patient dosing for the Phase 2 clinical trial of GI-301 in Japan—which was licensed to Maruho in 2023—is scheduled to begin this month.

This clinical trial is being led by Maruho, which holds the rights to develop and commercialize GI-301 in Japan. Previously, in May, Maruho submitted an Investigational New Drug (IND) application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase 2 clinical trial targeting patients with chronic spontaneous urticaria (CSU).

GI Innovation Inc. is set to receive a contractual development milestone payment upon the first patient dosing. The specific amount of the milestone payment was not disclosed.

In 2023, GI Innovation Inc. signed a technology transfer agreement with Maruho for GI-301 in Japan worth up to $221 million (approximately 300 billion won at the time). Maruho secured the rights to develop and commercialize GI-301 in Japan, while GI Innovation Inc. is structured to receive milestone payments based on development and commercialization stages, as well as royalties from product sales.

Since the technology transfer, the two companies have been coordinating their development strategy for Japan through the Joint Development Steering Committee (JSDC). On the 2nd, key executives and staff from Maruho visited GI Innovation Inc.’s Seongnam Research Institute to discuss the strategy for the Phase 2 clinical trial in Japan and the future development schedule.

GI-301 is an allergy treatment candidate developed by GI Innovation Inc. Maruho holds the development rights in Japan, while Yuhan holds the global development rights outside of Japan. Under the compound name “YH35324,” Yuhan(000100)is currently conducting a Phase 2 clinical trial in patients with CSU.

Jang Myung-ho, CEO of GI Innovation Inc., stated, “GI-301 is now entering full-scale Phase 2 clinical trials in Japan as well,” adding, “We will successfully conduct the Japanese clinical trials based on close collaboration with Maruho.”

Meanwhile, Maruho, founded in 1915, is a Japanese pharmaceutical company specializing in dermatology, with approximately 95% of its drug sales coming from the dermatology sector.