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

Toronto, Canada, May 26, 2021 – 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.