Overview
Zucara Therapeutics is developing the first once-daily therapeutic to prevent hypoglycemia (low blood sugar) in people with diabetes. The technology is directed at regulating a hormone in the pancreas called somatostatin which in Type 1 diabetes is not properly controlled. It has demonstrated potential to specifically block somatostatin type 2 receptors in the pancreas thereby preventing hypoglycemia. Zucara’s method offers a clear advantage as a preventative measure whereas current drug therapies can only rescue a person already experiencing potentially dangerous low blood sugar.
There are over 422 million people in the world living with diabetes and the WHO projects that diabetes will be the seventh leading cause of death in 2030. Insulin-treated patients include all Type 1 diabetics (T1D; ~5-10% of total patients) and ~15-25% of Type 2 diabetic patients (T2D). The primary goal of insulin therapy in the treatment of diabetes is to control hyperglycemia (high blood sugar levels). However, management of hyperglycemia with insulin is challenging because of the threat of acute and potentially life-threatening hypoglycemia (low blood sugar), the most significant side effect of insulin therapy.
Hypoglycemia is the primary limiting factor to successfully manage diabetes with insulin. 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 no current preventative therapy for hypoglycemia, leaving people with diabetes to completely rely on rescue therapy (glucose/glucagon).
History
Zucara Therapeutics was created in 2014 as a spin-out company by TIAP (Toronto Innovation Acceleration Partners) and adMare BioInnovations. Both institutions helped to establish the company providing management and R&D support.
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, developed compelling evidence that pancreatic cells that play a key role in regulating hypoglycemia via glucagon production are impaired in Type 1 diabetes. Their discoveries, using novel peptides that block somatostatin receptors, form a technology to restore the normal glucagon response and prevent hypoglycemia onset caused by insulin treatment.
Following the creation of the company by TIAP and adMare BioInnovations, the technology was developed through preclinical proof of concept by Zucara and is now in clinical development. These activities were supported by over US$5M in funding from organizations such as Breakthrough T1D (formerly JDRF), The Helmsley Charitable Trust, Mitacs, GlycoNet, and NRC-IRAP. The funding allowed Zucara to define its lead drug candidate, ZT-01 and complete IND/CTA enabling activities. In 2020, Zucara completed a US$21M Series A financing led by the Perceptive Xontogeny Venture Fund enabling several Phase 1 studies, including a positive proof-of-concept study. In 2024, Zucara raised US$20M in a Series B financing with existing investor, the Perceptive Xontogeny Venture Fund and strategic investor, Sanofi to complete Zucara’s ongoing Phase 2a trial of the effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes (“T1D”) mellitus (“ZONE”), and nonclinical activities to support a once-weekly version of ZT-01.