Astria Therapeutics, Inc. a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, announced that it has exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd., a Japanese specialty pharmaceutical company, for navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein, in Phase 3 development for the preventative treatment of hereditary angioedema (HAE). Under the agreement, Astria will receive an upfront payment of $16 million, with the potential for an additional $16 million in total commercialization and sales milestones. In addition to these payments, Astria is also eligible for tiered royalties with the royalty rate as a percentage of net sales up to 30%, and partial Phase 3 cost reimbursement.

“We are thrilled to partner with Kaken for the development and commercialization of navenibart in Japan, which advances our strategy to enable broad access to navenibart globally,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “In addition to our shared values that put patients first, Kaken brings strong relationships with the Japanese medical community that we believe will support both our Phase 3 ALPHA-ORBIT trial as well as the potential commercialization of navenibart in the future.”

“Our partnership with Astria for the development and commercialization of navenibart supports our strategy of providing therapies that address unmet medical needs in the Japanese community,” said Hiroyuki Horiuchi, President and Representative Director of Kaken. “We believe that navenibart is a complementary fit with our HAE portfolio, providing patients in Japan with the potential for low-burden treatments to better manage their disease.”

“As a physician that treats people with HAE, I am incredibly excited about the potential of a preventative therapy with navenibart’s profile,” said Dr. Michihiro Hide, President, Hiroshima City Hospital Organization. “I believe that navenibart could have a significant impact on the lives of HAE patients in Japan where people living with HAE are seeking options that allow them to be protected from their HAE attacks with very low treatment burden.”

Kaken will also provide support for the ALPHA-ORBIT Phase 3 trial in Japan, be responsible for regulatory submissions in Japan, and will reimburse Astria for a portion of the costs of the navenibart Phase 3 program.

Including the upfront payment from Kaken and the expected reimbursement by Kaken of a portion of the Company’s Phase 3 program costs, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.