GI-301 Allergy Treatment Enters Japanese Phase 2 Clinical Trials With First Patient Dosing Set for October
GI-Innovation announced that its allergy treatment GI-301, known generically as lesigerecept, is set to enter Japanese Phase 2 clinical trials with the first patient dosing scheduled for October. hankyung.com reported that Maruho, the Japanese partner holding local development and commercialization rights, submitted the Phase 2 Investigational New Drug application to Japan’s Pharmaceuticals and Medical Devices Agency in May. The upcoming milestone triggers a contractual development milestone payment to GI-Innovation.
Collaboration Strategy Between GI-Innovation and Maruho
The two companies have coordinated development strategies through regular Joint Steering Development Committee meetings since establishing their partnership. GI-Innovation previously licensed the regional rights for GI-301 to Maruho in 2023 in an agreement valued at up to $221 million, equivalent to approximately 300 billion Korean won at the time. Under the terms of the agreement, the South Korean biotech firm collects development and commercialization milestone payments alongside tiered royalties on future product sales.
GI-301 Enters Japanese Phase 2 Trials
Maruho’s Phase 2 clinical program focuses specifically on patients suffering from chronic spontaneous urticaria. Chief Executive Officer Myung-Ho Chang stated that the advancement of GI-301 into Japanese Phase 2 trials marks a broader expansion of the asset’s global development footprint. The companies plan to use their ongoing collaboration to validate the drug candidate's competitiveness within the global allergy treatment market.
What Condition Does GI-301 Treat in Japan?
What condition does GI-301 treat in the Japanese Phase 2 trial?
The clinical trial specifically targets patients diagnosed with chronic spontaneous urticaria. Maruho submitted the regulatory application for this indication to Japanese authorities in May.
When was the licensing agreement originally signed?
GI-Innovation and Maruho finalized their technology transfer agreement in 2023. The deal granted regional development and commercial rights to Maruho for up to $221 million.