– Phase 1 Trial to Evaluate ZT-01 for the Prevention of Insulin-Induced Hypoglycemia in Patients with Type 1 Diabetes –
TORONTO, Canada I September 29, 2020 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 subject in its Phase 1 trial of ZT-01.
“Initiation of our Phase 1 study of ZT-01, which has been our goal since establishing the Company in 2014, is a monumental milestone for Zucara,” said Michael Midmer, Zucara Therapeutics’ Chief Executive Officer. “Insulin-induced hypoglycemia is an underrecognized condition that causes fear and anxiety among diabetes patients and their loved ones. We are thrilled to enter the clinic with ZT-01 and look forward to gathering safety and pharmacodynamics data on this promising candidate, which we believe has the potential to improve disease management for the millions of patients who are at risk for dangerous hypoglycemic episodes.”
The study employs a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) trial design and will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT-01. The SAD portion of the study will enroll 40 healthy volunteers who will receive one of five escalating doses of ZT-01. The MAD portion of the study will follow the SAD portion and enroll 24 subjects with Type 1 diabetes (“T1D”) who will receive multiple escalating doses of ZT-01. The study is being 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 endocrine disorders.
The study results will help define ZT-01’s safety profile and establish doses to be used in an additional planned Phase 1 study to show the effect on glucagon during hypoglycemia in T1D patients.
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 in people with T1D by restoring the normal glucagon response. Glucagon is a hormone which stimulates the release of glucose from the liver when blood sugar levels drop too low.
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.
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– Phase 1 Trial to Evaluate ZT-01 for the Prevention of Insulin-Induced Hypoglycemia in Patients with Type 1 Diabetes –
TORONTO, Canada I September 29, 2020 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 subject in its Phase 1 trial of ZT-01.
“Initiation of our Phase 1 study of ZT-01, which has been our goal since establishing the Company in 2014, is a monumental milestone for Zucara,” said Michael Midmer, Zucara Therapeutics’ Chief Executive Officer. “Insulin-induced hypoglycemia is an underrecognized condition that causes fear and anxiety among diabetes patients and their loved ones. We are thrilled to enter the clinic with ZT-01 and look forward to gathering safety and pharmacodynamics data on this promising candidate, which we believe has the potential to improve disease management for the millions of patients who are at risk for dangerous hypoglycemic episodes.”
The study employs a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) trial design and will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT-01. The SAD portion of the study will enroll 40 healthy volunteers who will receive one of five escalating doses of ZT-01. The MAD portion of the study will follow the SAD portion and enroll 24 subjects with Type 1 diabetes (“T1D”) who will receive multiple escalating doses of ZT-01. The study is being 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 endocrine disorders.
The study results will help define ZT-01’s safety profile and establish doses to be used in an additional planned Phase 1 study to show the effect on glucagon during hypoglycemia in T1D patients.
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 in people with T1D by restoring the normal glucagon response. Glucagon is a hormone which stimulates the release of glucose from the liver when blood sugar levels drop too low.
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.
Post Views: 33
