Japanese partner Maruho leads trial; milestone payment expected upon first dosing

Chronic spontaneous urticaria targeted; Maruho executives visit Seongnam to discuss strategy

Japan development accelerates alongside Yuhan's global Phase 2 trial

Key executives from Japanese pharmaceutical company Maruho visit GI Innovation's Seongnam research center on Friday to discuss the Phase 2 trial strategy and development schedule for GI-301. [GI Innovation]
Key executives from Japanese pharmaceutical company Maruho visit GI Innovation's Seongnam research center on Friday to discuss the Phase 2 trial strategy and development schedule for GI-301. [GI Innovation]

GI Innovation's allergy treatment candidate GI-301 (generic name: lesigercept) has begun dosing its first patient in a Phase 2 trial in Japan, accelerating the drug's local development.

GI Innovation announced Wednesday that the first patient dosing in the Japanese Phase 2 trial of GI-301 — licensed to Japan's Maruho in 2023 — is set to take place this month. The company expects to receive a development milestone payment stipulated in the contract upon the start of dosing.

The trial is led by Maruho, which holds the rights to develop and commercialize GI-301 in Japan. Maruho submitted an investigational new drug application to Japan's Pharmaceuticals and Medical Devices Agency in May, targeting patients with chronic spontaneous urticaria, with the goal of dosing the first patient this month. Ahead of the trial's launch, senior Maruho executives visited GI Innovation's Seongnam research center on Friday to discuss the Japanese Phase 2 strategy and upcoming development timeline.

GI Innovation signed a technology licensing agreement with Maruho in 2023 worth up to $221 million (about 300 billion won at the time). Under the deal, GI Innovation is entitled to development and commercialization milestone payments as well as sales royalties, and the two companies have coordinated Japan development through regular joint steering and development committee meetings.

Maruho, founded in 1915, is a Japanese pharmaceutical company specializing in dermatology, with roughly 95 percent of its pharmaceutical sales coming from the skin disease segment — giving it a strong local retail and clinical infrastructure.

While Maruho holds the rights to GI-301 in Japan, Yuhan holds the global rights outside Japan under the project name YH35324 and is currently conducting a global Phase 2 trial in patients with chronic spontaneous urticaria. With the Japanese Phase 2 trial now fully under way, the pipeline's global commercialization timeline is expected to gain further momentum.

"GI-301 has now entered Phase 2 trials in Japan as well, marking a further expansion of its global development," said Jang Myung-ho, chief executive of GI Innovation. "Building on our partnership with Maruho, we will advance the Japanese trial successfully and demonstrate our competitiveness in the global allergy treatment market."


silverpaper@heraldcorp.com