Astria Therapeutics (ATXS) announced initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema patients. These results demonstrated robust overall reduction in the monthly attack rate. These results further support navenibart’s favorable safety and tolerability profile, and potential every three- and every six-month dosing regimens. Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date. All patients remain in the ALPHA-SOLAR trial. Navenibart was well-tolerated with no severe or serious treatment-emergent adverse events and no discontinuations. One participant experienced two treatment-related, mild injection site reactions that resolved without treatment. There were no injection site reactions of pain. The safety profile of navenibart in patients with HAE was favorable through more than 17 months of cumulative follow-up since the initiation of navenibart in ALPHA-STAR. The results shared above are available in a poster presented at the European Academy of Allergy and Clinical Immunology annual congress on June 13.
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