Zucara Therapeutics Announces Additional Funding from JDRF to Support ZT-01 Phase 2 Study

- Award to provide US$2 million to support Zucara's planned Phase 2a ZONE trial, with first patient dosing expected in Q3 2023 -

TORONTO, June 15, 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 additional funding from JDRF, the leading global Type 1 diabetes ("T1D") research and advocacy organization. Through its Industry Discovery & Development Partnerships ("IDDP") program, JDRF will provide US$2 million in funding to support Zucara's planned Phase 2a study of the effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes mellitus ("ZONE"). Zucara expects to begin patient dosing in the third quarter of 2023.

"JDRF has been a long-time partner of Zucara, supporting the development of ZT-01 from early discovery studies to this planned Phase 2 study soon underway," said Richard Liggins PhD, Zucara Therapeutics' Chief Scientific Officer. "We are grateful for JDRF's ongoing support. This funding underscores JDRF's prioritization of advancing adjunctive therapies to insulin reflecting a continuing unmet need for T1D patients. We are hopeful that the ZONE study will demonstrate that ZT-01 can prevent potentially dangerous and disruptive low blood glucose levels overnight, and lead to the first therapeutic to treat this unintended consequence of insulin therapy."

"Hypoglycemia remains a significant clinical challenge for people with T1D. Moreover, fear of hypoglycemia has great impact on quality of life for people with T1D and their caregivers. Therapies to prevent recurrent hypoglycemia, particularly overnight, are greatly needed," said Courtney Ackeifi, PhD, senior scientist at JDRF. "JDRF is excited to support Zucara's development of a novel therapy with the potential to protect against nocturnal hypoglycemia and help people with T1D achieve better glucose control."

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.

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

SOURCE Zucara Therapeutics Inc.