Astria Therapeutics has entered an exclusive licensing agreement with Kaken 色界吧 for the development and commercialisation rights of navenibart in Japan.
Navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein, is currently in Phase 3 development for the preventative treatment of hereditary angioedema (HAE), which causes recurrent episodes of severe swelling.
Astria will receive $16m upfront from Kaken and will be eligible for a further $16m in commercialisation and sales milestones. The agreement also includes tiered royalties up to 30% of net sales and partial Phase 3 cost reimbursement.
Astria Therapeutics CEO Jill C Milne stated: 鈥淲e are thrilled to partner with Kaken for the development and commercialisation of navenibart in Japan, which advances our strategy to enable broad access to navenibart globally.
鈥淚n 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 commercialisation of navenibart in the future.鈥�
Kaken 色界吧 president and representative director Hiroyuki Horiuchi stated: 鈥淥ur partnership with Astria for the development and commercialisation of navenibart supports our strategy of providing therapies that address unmet medical needs in the Japanese community.
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By GlobalData鈥淲e 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.鈥�
Kaken will support the ALPHA-ORBIT Phase 3 trial in Japan and handle regulatory submissions.
Astria anticipates that its cash, cash equivalents and short-term investments will fund its current operating plan into 2028.
Astria鈥檚 aim with Navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism, administered subcutaneously every three to six months. Astria鈥檚 lead programme, navenibart (STAR-0215), is complemented by STAR-0310, a monoclonal antibody OX40 antagonist for atopic dermatitis (AD).
In 2023, Astria Therapeutics signed an exclusive global agreement to license Ichnos Sciences鈥� OX40 portfolio to treat AD.
Kaken focuses its research and development on areas such as immune, nervous and infectious diseases, and on rare diseases with unmet medical needs.
