ZZ Biotech Announces Preliminary Phase 2 Stroke Trial ResultsJan 29, 2018
ZZ Biotech Announces Preliminary Phase 2 Stroke Trial Results with 3K3A-APC
Houston, TX, USA, January 29, 2018 / B3C newswire / — ZZ Biotech today announced that preliminary results of RHAPSODY, the company’s Phase 2 clinical trial in acute ischemic stroke patients, were presented at the 2018 International Stroke Conference in Los Angeles.
The placebo-controlled dose-escalation trial was designed to establish a maximally tolerated dose (MTD) of 3K3A-APC in patients with acute ischemic stroke treated with intravenous tPA, intra-arterial thrombectomy, or both. A secondary endpoint was to evaluate the effect of 3K3A-APC on cerebral hemorrhage in this patient population. Study participants, aged 18-90, were followed for 90 days.
The experimental drug 3K3A-APC is a genetically engineered variant of the naturally occurring activated Protein C, which plays a role in the regulation of blood clotting and inflammation. In animal models of stroke, 3K3A-APC has helped prevent bleeding caused by tPA, the only drug currently indicated for the treatment of acute ischemic stroke.