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.
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.
