Astria Therapeutics has reported encouraging initial outcomes from its ongoing ALPHA-SOLAR trial of monoclonal antibody inhibitor of plasma kallikrein, navenibart (STAR-0215), in patients with hereditary angioedema (HAE).
The long-term, open-label study is designed to evaluate the safety and efficacy of the antibody in adult patients with HAE Type 1 or 2.
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According to the company, the study has revealed an overall decrease in the monthly attack rate, strengthening the evidence for the antibody’s favourable tolerability and safety profile and its potential for every three-month (Q3M) and every six-month (Q6M) dosing regimens.
The Q3M arm of the trial showed a 95% mean decrease in the monthly attack rate, while the Q6M arm showed an 86% reduction.
All 16 target enrolment subjects from the Phase Ib/II ALPHA-STAR study elected for enrolling in the ALPHA-SOLAR trial.
Subjects from Cohorts 1 and 2 of ALPHA-STAR were enrolled in Arm A, and those from Cohort 3 in Arm B.
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By GlobalDataAstria noted that the antibody has shown a 50% overall attack freedom over a six-month period.
The trial participants have remained in the ALPHA-SOLAR study, with the antibody being well-tolerated without any serious or severe treatment-emergent adverse events (TEAEs) and discontinuations.
The antibody’s safety profile in HAE patients was found to be favourable, with more than 17 months of cumulative follow-up since the commencement of the antibody in the ALPHA-STAR trial.
Astria Therapeutics chief medical officer Christopher Morabito said: “We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial. Results are consistent with navenibart’s best-in-class profile that we saw in the ALPHA-STAR Phase Ib/II trial.
“With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart’s favourable profile and the potential to administer navenibart every three and every six months.”
In February this year, the company began the randomised Phase III ALPHA-ORBIT trial assessing navenibart to treat HAE.
