ZZ Biotech’s regenerative bio drugs manufactured in Brisbane with support of Biopharmaceuticals Australia
ZZ Biotech was awarded a $250,000 grant by BPA to support clinical development of its lead drug product, 3K3A-APC. The drug was manufactured at Patheon’s state-of-the-art contract manufacturing located in Brisbane, and will be used in animal studies and Phase 2 clinical trials targeting ischemic stroke and diabetic foot ulcers.
Ischemic stroke is the third leading cause of death and the most common cause of disability in industrialized nations and healthcare costs run to billions of dollars. ZZ Biotech’s modified APC has anti-inflammatory, anti-apoptotic and regenerative activities which aim to reduce the impact of stroke. ZZ Biotech has already shown the product to be safe in a Phase 1 trial.
The global chronic wound market comprises diabetic foot ulcers, venous leg ulcers, pressure sores and orthopaedic wounds and affect ~1.5% of the general population. In the USA, >6.5 million people have lower leg ulcers, with annual treatment cost of >$25 billion. Similar trends are seen worldwide.
Kent Pryor, CEO ZZ Biotech said, “The manufacturing campaign at Patheon’s Brisbane facility has been successful, and will enable ZZ Biotech to complete our Phase 2 stroke study and to commence the pre-clinical animal studies that are a prerequisite for the planned multi-center human wound-healing studies in Australia and USA.”
BPA’s CEO David Hughes said “We are very happy to assist ZZ Biotech establish its clinical development capability in Queensland. Valuable export income is being earned for Australia, not only from the supply contract with Patheon, but also with other local clinical trials services companies. This deal-flow creates and maintains high quality jobs in advanced manufacturing and other cutting edge disciplines”.
BPA is dedicated to fostering the growth of the Australian biopharmaceuticals industry. It is a wholly owned company of the Queensland State Government. BPA’s core activity has been the design and construction of a state-of-the-art contract manufacturing facility in Brisbane. The facility opened in 2013 and is operated by Patheon Biologics under a long term leasing deal. The AUD65M facility was awarded the 2014 ISPE Facility of the Year (process innovation category). Since handing over the facility to Patheon, BPA has provided ongoing support for the commercial translation of early-stage biomedical drug prospects via its unique $2 million Biopharmaceutical Development Fund. This program offers supported-access to the manufacturing services provided by the Patheon as well as establishment grants for international companies setting-up local subsidiaries for clinical drug development.
For more information about BPA and the BDF program visit www.biopharmaus.com.au.
About ZZ Biotech, LLC
ZZ Biotech is a company headquartered in Houston, USA with a recently-established Australian subsidiary. The company’s mission is to develop innovative regenerative treatments for multiple disease indications. The most advanced use for the experimental biological drug, named 3K3A-APC, is ischemic stroke, through its impact upon regulation of blood clotting and inflammation. The cell protective effects of 3K3A-APC will also target chronic wound applications, initially diabetic foot ulcers.