ZZ Biotech

ZZ Biotech is a clinical stage company developing innovative biologic treatments for ischemic stroke, neurological diseases and wound healing applications including the treatment of diabetic foot ulcers. ZZ Biotech was incepted in 2006 to focus on the development of 3K3A-APC, a novel second-generation variant of a naturally occurring human protein licensed from The Scripps Research Institute. ZZ Biotech’s experimental drug 3K3A-APC is a genetically engineered variant of human activated protein C (APC), a serine protease optimized for human therapeutic use. ZZ Biotech completed RHAPSODY, a placebo-controlled multicenter Phase 2 clinical trial of 3K3A-APC in patients suffering from acute ischemic stroke. The study was supported and funded by the NIH’s National Institute of Neurological Disorder and Stroke (NINDS) through a pair of NeuroNEXT grants. The Phase 2 study evaluated safety, tolerability and vasculoprotective activity of 3K3A-APC when given after tissue plasminogen activator (tPA), mechanical thrombectomy, or both, in patients who have experienced moderate to severe ischemic stroke. 3K3A-APC was deemed safe and well-tolerated at all dose levels tested. Furthermore, intracerebral bleeding was substantially reduced in patients treated with 3K3A-APC. In June 2020 the FDA designated the investigation of the ZZ Biotech’s experimental drug 3K3A-APC for the treatment of acute ischemic stroke as a Fast Track development program. In May of 2022 the NINDS awarded $4 million of a grant budgeted to total approximately $30 million to researchers at the Keck School of Medicine of USC to conduct a pivotal Phase 3 clinical trial in acute ischemic stroke using 3K3A-APC. The multinational trial, to be run in the NIH StrokeNet, will commence in 2023. ZZ Biotech also has active clinical programs in ALS and wound healing. 3K3A-APC’s unique multi-modal mechanism of action is well suited to address both of these areas of great unmet medical need.