Astria Therapeutics will launch a new study to assess the safety, tolerability, activity, pharmacokinetics, pharmacodynamics, and immunogenicity of STAR-0215, a novel therapy for patients with hereditary angioedema (HAE).
The phase 1b/2, interventional, single- and multiple-dose, nonrandomized study is expected to start in February 2023 and will enroll 18 adult participants with type 1 or 2 HAE.
The participants will be divided into 2 dose cohorts; one will receive a single subcutaneous dose of STAR-0215 and the other will receive 2 subcutaneous doses 3 months apart. The primary outcome measure will be the number of participants with treatment-emergent adverse effects.
Secondary outcome measures include changes from baseline in HAE attack rate (per month), severity and duration of attacks, time interval to attacks after STAR-0215 dosing, serum concentrations of STAR-0215, plasma kininogen levels, and the number of participants with antidrug antibodies.
Read more about HAE therapies
Hereditary angioedema is a genetic condition caused by a mutation in the SERPING1 gene, which codes for C1-inhibitor (C1-INH), and it is characterized by repeated swelling episodes, particularly in the face, limbs, airway, and intestinal tract. HAE is caused by an absence or deficiency of C1-INH, and is classified as type 1, which is due to a reduced quantity of C1-INH, and type 2, which is caused by dysfunctional C1-INH protein. A third type has recently been identified in which patients have normal C1-INH.
STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein, with the aim of sustained prevention of HAE attacks. A phase 1a trial of the therapy showed rapid and long-lasting kallikrein inhibition for up to 110 days in healthy volunteers. The results revealed the potential for dosing once every 3 months or even less frequently, which will be assessed in upcoming studies.
The new study is expected to deliver preliminary results in mid-2024. Astria also plans to assess the potential for 6-month dosing of STAR-0215 in another phase 1a trial expected to start in the first quarter of 2023.
A study of STAR-0215 in participants with hereditary angioedema. ClinicalTrials.gov. January 23, 2023. Accessed January 27, 2023.