Navenibart

BOSTON--( BUSINESS WIRE )-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present two posters at the upcoming Bradykinin Symposium in Berlin, Germany on September 6, 2024. Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics, will present information on ALPHA-SOLAR, a long-term open-label trial of navenibart (STAR-0215) in people living with HAE, in an encore presentation of a poster titled “Rationale and Design of the ALPHA-SOLAR Clinical Trial of STAR-0215.” Kusumam Joseph, Senior Director of Medical Affairs at Astria Therapeutics, will present results from the Phase 1a trial of navenibart (STAR-0215) in an encore presentation of a poster titled “Phase 1a Trial of STAR-0215 for Hereditary Angioedema: Updated Results.” Both posters will be presented at the poster session on Friday, September 6, at 3:35pm CEST. About Astria Therapeutics: Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com , or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn.

A patient with hereditary angioedema (HAE). Image credit: Velimir Zeland / Shutterstock. Astria Therapeutics has selected Ypsomed’s Ypsomate autoinjector as its partner for the administration of STAR-0215 for the treatment of hereditary angioedema (HAE). US-based Astria’s lead candidate, STAR-0215, is a long-acting monoclonal antibody inhibitor of plasma kallikrein for the treatment of HAE. It received fast track designation from the US Food and Drug Administration (FDA) last year and is currently under evaluation in its Phase Ib/II ALPHA-STAR trial  (NCT05695248). HAE is a rare genetic disorder. Caused by low levels or the improper functioning of the C1 inhibitor protein, it causes recurrent bouts of severe swelling in patients. Initial proof-of-concept results from the ALPHA-STAR trial were shared in March 2024 and showed that STAR-0215 dosed once or twice over six months reduced monthly HAE attack rates by 90%-96%. Swiss medtech Ypsomed’s Ypsomate autoinjector comes in several size variants for the self-administration of liquid medications. See Also: NorthStar and Convergent expand deal for prostate cancer drug Baxter signs over kidney care arm to investment firm in $3.5bn deal Pending regulatory approval, Astria said it plans to launch STAR-0215 with the Ypsomed YpsoMate autoinjector and a pre-filled syringe, the aim being to develop an HAE therapy that allows patients to choose an approach that works best for their lives with the option of infrequent three- and six-month administration. John Ruesch, senior vice president of pharmaceutical sciences and technical operations at Astria, said: “Our partnership with Ypsomed, a leading developer and manufacturer of injection systems, supports this goal through the planned development of an autoinjector that enables our vision for STAR-0215 to be a therapy that can effectively protect against HAE attacks while also having a very low burden of treatment and administration.” GlobalData’s Clinical Trials database indicates there are around 200 clinical trials in HAE at various stages of active development. In addition, the company’s database indicates there are around 30 pipeline drugs in active development. According to GlobalData, preregistered drugs for HAE have an 85.71% likelihood of approval indication benchmark. GlobalData is the parent company of Pharmaceutical Technology.