Zucara Therapeutics Receives IND Clearance for Phase 2 Clinical Trial of ZT-01

- First patient dosing expected in Q3 2023 -

- ZONE study to assess ZT-01's ability to prevent night-time hypoglycemia, a condition for which there are currently no available therapies -

TORONTO, April 19, 2023 /PRNewswire/ - Zucara Therapeutics Inc., ("Zucara" or the "Company") a diabetes-focused life sciences company developing the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for ZT-01 for the prevention of night-time (nocturnal) hypoglycemia in patients with Type 1 Diabetes ("T1D"). The FDA's clearance enables Zucara to initiate its planned trial titled A Phase 2a study of effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes mellitus (ZONE), with first patient dosing expected to occur in the third quarter of 2023.

Zucara recently announced positive results from its proof-of-concept Phase 1b study of ZT-01 in people with T1D demonstrating that nearly 90% of subjects had a meaningful increase in glucagon release following ZT-01 administration, compared to placebo, with no serious adverse events observed. Glucagon has the opposite effect of insulin and increases blood glucose levels. In people with T1D, the mechanism for glucagon release is disrupted.

"We are thrilled to have reached this important milestone and eager to initiate our planned Phase 2 trial for the prevention of nocturnal hypoglycemia, a frequent occurrence for people with insulin-dependent diabetes that is a significant cause of anxiety for both patients and their loved ones," said Susan Peers PhD, Zucara Therapeutics' Director of Clinical and Regulatory Affairs. "Having demonstrated proof-of-concept and ZT-01's ability to significantly increase glucagon release in patients with T1D, we are looking forward to showing we can prevent potentially dangerous low blood glucose levels overnight. We are excited to take the next step in developing what could be the first therapeutic available to prevent night-time hypoglycemia."

The ZONE study is a multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, crossover study designed to evaluate the effect of ZT-01 on the frequency of nocturnal hypoglycemia in patients with T1D. Patients will self administer one of three doses of ZT-01, or placebo, every evening before bed each for a four-week period. Patients will be monitored for hypoglycemia events using a continuous glucose monitor. The study's primary endpoint is the rate of nocturnal hypoglycemic events, compared to placebo. Secondary endpoints include the number of patients experiencing adverse events and time spent in hypoglycemia, compared to placebo.

ZT-01 is designed to prevent potentially dangerous low blood glucose levels by restoring the body's ability to counter-regulate hypoglycemia. In people without diabetes, α-cells secrete glucagon that signals the body to release its own glucose stores, thus preventing hypoglycemia. However, in people with insulin-dependent diabetes – including those with T1D and insulin-dependent Type 2 diabetes – evidence suggests that elevated secretion of pancreatic somatostatin ("SST") suppresses glucagon release from α-cells. Zucara has demonstrated that, in people with T1D, the glucagon response can be increased with ZT-01, a first-in-class SST receptor 2 antagonist.

Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent hypoglycemia in people with T1D and insulin-dependent Type 2 diabetes. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with these conditions. ZT-01 is designed to restore 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.