February 22, 2021 – Edmonton, Alberta
A drug discovered in Edmonton has just been approved by the FDA — nearly 28 years after a University of Alberta professor first started the pharmaceutical company in a room in his basement.
Dr. Robert Foster, an adjunct professor in the Faculty of Pharmacy and Pharmaceutical Sciences, founded Isotechnika Pharma in 1993 and discovered voclosporin, which was approved in January by the U.S. Food and Drug Administration (FDA) as Lupkynis to treat patients with lupus-related kidney disease.
“My role was in the early stages in getting the drug and the company off the ground. There wouldn’t have been anything to develop if I hadn’t left a tenured faculty position to develop this molecule,” says Foster. “But getting a drug to this point takes a village. At one point, Isotechnika had about 150 employees in Edmonton.”
Isotechnika licensed the rights of voclosporin to Aurinia Pharmaceuticals, and eventually it bought the company and name. Foster was CEO until 2014.
In 2018, Foster was appointed CEO of New Jersey-based Hepion Pharmaceuticals and he immediately made Edmonton the primary site for the company’s research and development. Foster recruited former Isotechnika staff members Daren Ure, Daniel Trepanier, and Patrick Mayo, to his senior executive team and contracted Applied Pharmaceutical Innovation to enhance the company’s capacity. Foster and his team are committed to creating life- saving treatments for serious disease and continue to work with molecules that they first discovered with Isotechnika.
Their focus now is liver disease, including non-alcoholic steatohepatitis (NASH), a disease that causes liver inflammation and damage by a buildup of fat in the liver. It is part of a group of conditions called non-alcoholic fatty liver disease.
“The NASH market potential is huge,” says Foster. It’s estimated NASH affects 17 million adults in the U.S. and 1.5 million Canadians.
Hepion is currently in phase two trials, and has raised well over $200 million US to fund its research and Foster expects this to continue to grow. It closed its latest public offering on Feb. 18, raising about $88 million US in less than a week. The amount brought in by the company is one of the largest raises in the province for a company with a significant presence in Alberta.
Many people are unaware of the exciting scientific research and development in Edmonton, says Foster, and he credits the world-calibre expertise at the University of Alberta and the support of the Applied Pharmaceutical Innovation (API) in the success of Hepion and the province’s broader research community.
Every person who worked on the earlier development of Lupkynis all the way up to FDA approval had a U of A connection at one point.
“This is an Edmonton story. And we’re going to do it again.”
Hepion is getting a lot of profile in New York for its work, Foster notes, but few in Edmonton are aware of its research. There are clinical trials going on now in 10 different sites in the U.S., and in the fall there will be broader trials in Canada, the U.S. and Europe.
“API is thrilled to be working closely with Hepion, and we look forward to seeing their continued success. Alberta’s next biotech star is rising thanks to the leadership of Dr. Foster and the team of life sciences experts in the region,” says Andrew MacIsaac, CEO of API.
More About Hepion Pharmaceuticals: The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in preclinical studies. Hepion has created a proprietary AI platform, called AI- POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
More About Applied Pharmaceutical Innovation (API): With a network of over 30 pharmaceutical scientists, clinicians, regulatory, patent and market experts, Applied Pharmaceutical Innovation (API) helps bring life-saving research to the real world. API is a not-for-profit institution with an expert interdisciplinary team that works with a network of collaborating organizations to provide the expertise, services, and infrastructure of a pharmaceutical company. API helps innovators launch their ideas into the real world, connects industry to the services they need for commercial success, and accelerates all aspects of the drug development process. API provides industry partner access to translational science in a framework that supports commercial success, as well as provides the services and resources by delivering expertise in drug development.