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Zucara Therapeutics begins patient dosing in phase 2a ZONE trial

Toronto, Canada
Tuesday, September 26, 2023, 18:00 Hrs  [IST]

Zucara Therapeutics Inc., (Zucara), a diabetes life sciences company, announced that it has dosed the first patient in its phase 2a trial of the effect of ZT-01 On Nocturnal hypoglycaemia Events in Type 1 diabetes (T1D) mellitus (ZONE).

“Dosing the first patient in Zucara’s ZONE trial is the company’s most significant milestone to date, and advances what could be the first preventative solution to potentially dangerous nighttime low blood glucose levels,” said Michael Midmer, Zucara Therapeutics’ chief executive officer. “Nighttime hypoglycaemia remains a significant challenge in diabetes management and is a great source of fear for people with diabetes, parents and their caregivers. We believe ZT-01 could greatly improve quality of life by preventing these low blood sugar events which are an ongoing disruption to many people with T1D and can lead to serious complications and poorer health outcomes.”

The ZONE study is a multi-centre, randomized, double-blinded, placebo-controlled, multiple-dose, crossover study designed to evaluate the effect of ZT-01 on the frequency of nocturnal hypoglycaemia 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 hypoglycaemia events using a continuous glucose monitor. The study’s primary endpoint is the rate of nocturnal hypoglycaemic events, compared to placebo. Secondary endpoints include the number of patients experiencing adverse events and time spent in hypoglycaemia compared to placebo.

Dr. Alex Abitbol, who previously evaluated ZT-01 in a phase 1b study and will be a principal investigator for ZONE, commented, “The positive results from the proof-of-concept phase 1b study of ZT-01 were intriguing: in addition to observing a rise in glucagon, we also saw a corresponding rise in glucose during hypoglycaemia. This suggests that ZT-01 can prevent nocturnal hypoglycaemia, which is what we aim to confirm in the ZONE trial.”

The ZONE study is actively recruiting and will enroll patients at as many as 15 clinical sites across Canada and the US Recruitment is expected to be completed in 2024.

Zucara previously announced positive results from its proof-of-concept phase 1b study of ZT-01 in people with T1D demonstrating that nearly 90% of patients had a meaningful increase in glucagon release following ZT-01 administration, compared to placebo, with no serious adverse events observed.

ZT-01 is designed to prevent potentially dangerous low blood glucose by restoring the body’s ability to counter regulate hypoglycaemia. In people without diabetes, a-cells secrete glucagon that signals the body to release its own glucose stores to prevent or reverse hypoglycaemia. 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 suppresses glucagon release from a-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 hypoglycaemia 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 hypoglycaemia in people with these conditions.


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