Astria Therapeutics, Inc. has entered into an exclusive licensing agreement with Kaken Pharmaceutical Co., Ltd., granting Kaken the rights to develop and commercialize navenibart in Japan for the preventive treatment of hereditary angioedema (HAE). Navenibart is a long-acting monoclonal antibody inhibitor of plasma kallikrein currently in Phase 3 clinical trials.
As part of the agreement, Astria will receive a $16 million upfront payment, with the potential for an additional $16 million in development and sales milestones. The deal also includes tiered royalties on net sales of up to 30%, along with partial reimbursement of Phase 3 clinical trial costs.
“We are thrilled to partner with Kaken for the development and commercialization of navenibart in Japan,” said Jill C. Milne, Ph.D., CEO of Astria Therapeutics. “Kaken’s deep relationships with the Japanese medical community and shared commitment to putting patients first make them an ideal partner to support our ALPHA-ORBIT Phase 3 trial and future commercialization efforts.”
Kaken will lead regulatory submissions in Japan and contribute to the local execution of the ALPHA-ORBIT trial, a global Phase 3 study evaluating navenibart’s potential as a low-burden preventive therapy for HAE.
“Our collaboration with Astria aligns with Kaken’s mission to bring innovative therapies to Japanese patients with unmet medical needs,” said Hiroyuki Horiuchi, President and Representative Director of Kaken. “We believe navenibart is a strong addition to our HAE portfolio and could offer patients a valuable new treatment option.”
Dr. Michihiro Hide, President of the Hiroshima City Hospital Organization, also expressed optimism about the therapy’s potential: “Navenibart could have a significant impact on the lives of HAE patients in Japan, offering protection from attacks with very low treatment burden.”
With the Kaken partnership and the expected reimbursement of part of its development costs, Astria projects that its current cash reserves will fund operations into 2028.
The collaboration represents a key step in Astria’s global expansion strategy, bringing its lead HAE candidate closer to patients in Asia and building momentum for broader commercialization of navenibart.