Zucara Therapeutics Doses First Patients in Phase 1b Trial of ZT-01

 Proof-of-Concept Trial to Evaluate the Effect of ZT-01 on Insulin-Induced Hypoglycemia in Patients with Type 1 Diabetes –

TORONTO, Canada I July 28, 2021 I Zucara Therapeutics Inc., 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 dosed the first patients in its Phase 1b trial of ZT-01.

"We are excited to advance ZT-01 to the next stage of development after our recent successful completion of a Phase 1 safety and pharmacokinetics study," said Richard Liggins, Zucara Therapeutics' Chief Scientific Officer. "The current trial aims to prove ZT-01's mechanism of action to show we can restore normal glucagon function following a hypoglycemia challenge in people with T1D."

The study will enroll up to approximately 25 Type 1 diabetes ("T1D") patients who will undergo a hypoglycemic clamp procedure including administration of either ZT-01 or placebo. The main objective of the study is to evaluate the effect of ZT-01 on glucagon levels. Other study objectives include further evaluation of the safety and tolerability of ZT-01 and evaluation of symptoms and other hormones related to hypoglycemia. Topline results are expected in the first quarter of 2022.

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.

Zucara recently completed a single and multiple ascending dose Phase 1 trial, in which ZT-01 was safe and well-tolerated. The most common adverse events were mild redness and swelling at the injection site, with no serious adverse events observed.

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

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