ZZ Biotech's 3K3A-APC reduces hemorrhage rate in Phase II for acute ischemic stroke

ZZ Biotech LLC (Houston, Texas) reported preliminary data from the Phase II RHAPSODY trial in 110 patients with moderate to severe acute ischemic stroke who were treated with IV tissue plasminogen activator (tPA), intra-arterial thrombectomy or both showing that 3K3A-APC significantly reduced the incidence of any hemorrhage vs. placebo (67.4% vs. 86.5%, p=0.046). 3K3A-APC was well tolerated. Data were presented at the International Stroke Conference in Los Angeles. Patients received placebo or 120, 240, 360 or 540 μg/kg 3K3A-APC every 12 hours for up to five doses.

The double-blind, U.S. trial’s primary endpoint is safety. Secondary endpoints include pharmacokinetics, hemorrhage rate and antibody formation...