Zucara Therapeutics Successfully Completes Single and Multiple Ascending Dose Phase 1 Trial of ZT-01

TORONTO, May 26, 2021 /PRNewswire/ - Zucara Therapeutics Inc. ("Zucara" or the "Company"), a diabetes life sciences company developing the first once-daily therapeutic to prevent insulin-induced hypoglycemia (low blood glucose levels), today announced that it has successfully completed a Phase 1 study evaluating single and multiple ascending doses of ZT-01.

"We are pleased with the results of the Phase 1 trial, which demonstrated that ZT-01 was safe and well-tolerated," said Michael Midmer, Zucara Therapeutics' Chief Executive Officer. "In addition, the results have guided dose selection of ZT-01 to be used in a planned proof-of-concept Phase 1b study that we expect to initiate in the third quarter of this year."

Dr. Alex Abitbol, the study's principal investigator, added, "ZT-01's favourable safety and tolerability profile in healthy adult subjects and subjects living with type 1 diabetes (T1D) are encouraging. Hypoglycemia (low blood sugar) remains a common, recurring, and often unrecognized problem, even today. A novel treatment to prevent hypoglycemia would be a welcome tool and indispensable safeguard for people living with T1D."

The Phase 1 trial was designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT-01. The single ascending dose (SAD) part enrolled 40 healthy volunteers who received one of five escalating doses of ZT-01, or placebo. The multiple ascending dose (MAD) part enrolled 24 subjects with T1D who received multiple escalating doses of ZT-01, or placebo. No serious adverse events were observed. The most common adverse events were mild redness and swelling at the injection site.

Based on these results, Zucara plans to initiate a proof-of-concept Phase 1b clinical trial, which will evaluate ZT-01's effect on glucagon levels during a hypoglycemic challenge in T1D patients. The study will be conducted at LMC Manna Research, the largest network of fully owned and integrated clinical research sites in Canada, providing Phase 1-4 clinical trial services with a specialized focus on diabetes and general endocrine disorders.

Insulin-induced hypoglycemia is a frequent, unintended consequence of insulin therapy for people with T1D and other types of insulin-dependent diabetes. Hypoglycemia is associated with significant morbidity and mortality, yet there are currently no available therapeutics to prevent the condition. ZT-01 is designed to prevent hypoglycemia by restoring the normal glucagon physiology, which is disrupted in T1D.

About Zucara Therapeutics Inc.

Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent insulin-induced hypoglycemia in patients using insulin therapy. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with insulin dependent diabetes. ZT-01 restores glucagon secretion to prevent hypoglycemia, which could dramatically change diabetes disease management and improve both patient health and quality of life. For more information, visit www.zucara.ca.

SOURCE Zucara Therapeutics Inc.