ZZ Biotech is a clinical stage biopharmaceutical company advancing new treatments for some of the biggest unmet needs in stroke, neurodegenerative disease and chronic wound healing. Our lead drug, 3K3A-APC, is a genetically engineered variant of human activated protein C (APC), a serine protease, optimized for human therapeutic use.
In June 2020 the FDA designated the investigation of ZZ Biotech’s experimental drug 3K3A-APC for the treatment of acute ischemic stroke as a Fast Track development program. FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to get important new drugs to the patient earlier.
In May of 2022 the NINDS awarded 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 ZZ Biotech’s 3K3A-APC. The multinational trial, to be run in the NIH StrokeNet, will commence in 2023.
ZZ Biotech also has active clinical programs in wound healing and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. 3K3A-APC’s unique multi-modal mechanism of action is well suited to address both of these areas of great unmet medical need. ZZ Biotech commenced a Phase 2 clinical biomarker study in ALS in December 2021. The study is being conducted at Macquarie University, in Sydney, Australia, and seeks to investigate whether 3K3A-APC is safe and potentially effective in patients with ALS. The Firies Climb for Motor Neurone Disease provided an AU$1 million donation to support this clinical trial.