Diabetes affects more than 422 million people worldwide, and according to the World Health Organization, the disease will be the seventh leading cause of death in 2030. Patients with insulin-dependent diabetes use insulin therapy to control hyperglycemia (high blood sugar levels). Unfortunately, the most significant side effect of insulin therapy is hypoglycemia (low blood sugar). Severe hypoglycemic episodes can be life-threatening and are a particular source of fear and anxiety for those living with diabetes. Hypoglycemia also impacts the incidence of complications of diabetes, including cardiovascular effects, which dramatically affect both patient health and the cost of care.
Despite this unmet clinical need, there is currently no preventative therapy for hypoglycemia, which leaves people with diabetes completely reliant on glucose or glucagon ‘rescue’ therapy.
Zucara Therapeutics is developing the first once-daily therapeutic to prevent hypoglycemia in people with diabetes. In these patients, a pancreatic hormone called somatostatin is not properly controlled, which leads to the suppression of glucagon, another pancreatic hormone that enables hypoglycemia recovery. Zucara’s lead drug candidate, ZT-01, is designed to regulate somatostatin, thereby restoring the normal glucagon response and preventing hypoglycemia. ZT-01 offers the potential to prevent hypoglycemia, in contrast to current drug therapies that only ‘rescue’ a person already experiencing potentially dangerous low blood sugar levels.
ZT-01 is currently in clinical trials and has completed Phase 1 studies to show that it is safe and well-tolerated, with no serious adverse events. The Company has now progressed into a proof-of-concept Phase 1b study that aims to prove ZT-01’s mechanism of action in restoring the normal biology required to prevent hypoglycemia. Topline results are expected in the second quarter of 2022.
Zucara Therapeutics is a spin-out company created in late 2014 by TIAP (Toronto Innovation Acceleration Partners) and adMare BioInnovations. Zucara’s academic founders, Drs. Mladen Vranic (Banting and Best Diabetes Centre, University of Toronto), Michael Riddell (York University), David Coy (Tulane University) and Richard Liggins, Chief Scientific Officer, discovered novel peptides that block somatostatin receptors, restore the normal glucagon response and prevent hypoglycemia onset caused by insulin treatment.
Zucara’s preclinical research was supported by more than US$7M in seed funding from organizations such as JDRF International (US$0.8M) and The Helmsley Charitable Trust (US$3.9M in the form of a Program Related Investment). In March 2020, the Company secured a US$21M Series A financing led by the Perceptive Xontogeny Venture Fund that will support ZT-01’s Phase 1 and Phase 2 clinical development.
