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

Zucara Therapeutics, 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 US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application for ZT-01 for the prevention of night-time (nocturnal) hypoglycemia in patients with Type 1 Diabetes. 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.