ZZ Biotech LLC is a clinical stage company developing innovative biologic treatments for ischemic stroke. ZZ Biotech was formed in 2006 to focus on the development of 3K3A-APC, a novel second-generation variant of a naturally occurring human protein, activated Protein C (APC). The major unwanted side effect of APC is bleeding, which limits its pharmacologic dosing in man. 3K3A-APC has markedly reduced anticoagulant activity, but preserved cell-protective and anti-inflammatory activities compared to wild-type APC. In animal models of stroke 3K3A-APC has shown an advantage over wild-type APC in enhanced efficacy and reduced risk for bleeding. Additionally, the combination of 3K3A-APC and tissue Plasminogen Activator (tPA) provides benefits well beyond those found with either agent alone.
ZZ Biotech has completed a multicenter Phase 2 clinical trial (RHAPSODY) of 3K3A-APC in moderate to severe acute ischemic stroke patients treated with intravenous tPA, intra-arterial thrombectomy, or both. The study was supported by the National Institutes of Health through a pair of NeuroNEXT grants. RHAPSODY established the maximally-tolerated dose (MTD) of 3K3A-APC in ischemic stroke patients and demonstrated substantial reduction in both total hemorrhage volume and hemorrhage incidence among patients treated with 3K3A-3PC vs. those treated with placebo.