Zucara Therapeutics' Positive Proof-of-Concept Data Secures Continued Funding Ahead of Planned Phase 2 Clinical Trial of ZT-01

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Sep 19, 2022, 07:30 ET

Achieves development milestones required to complete Series A financing –
Plans to file Phase 2 investigational new drug (IND) application by year end, with first patient dosing in Q1 2023 –

TORONTO, Sept. 19, 2022 /PRNewswire/ - Zucara Therapeutics Inc., ("Zucara" or the "Company") a diabetes life sciences company developing the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced that its positive proof-of-concept data has enabled the Company to secure continued funding for a Phase 2 clinical study of ZT-01, which is expected to begin in Q1 2023.

Zucara recently announced positive results from its proof-of-concept Phase 1b study of ZT-01 in people with Type 1 diabetes ("T1D") demonstrating that nearly 90% of subjects had a meaningful increase in glucagon following ZT-01 administration, compared to placebo, with no serious adverse events observed. These positive data have enabled the Company to advance ZT-01's development program, such that Zucara plans to file an investigational new drug ("IND") application for a Phase 2 trial by year end, with initiation of first patient dosing expected in Q1 2023.

"We are incredibly encouraged by the results of our Phase 1b trial, which confirmed ZT-01's mechanism of action in restoring glucagon release in patients with T1D," said Michael Midmer, Zucara Therapeutics' Chief Executive Officer. "We are also very pleased to have met the development milestones necessary to secure continued funding and are grateful for our ongoing investor support as we advance ZT-01 to Phase 2 clinical studies."

Zucara has achieved the development milestones required to secure the remaining funds available from its previously announced US$21 million Series A Financing led by the Perceptive Xontogeny Venture Fund ("PXV Fund"). The remaining funds will support Zucara's planned multi-centre Phase 2 trial, whose objective is to determine whether low blood sugar can be prevented overnight in patients with T1D. Patients will receive ZT-01 nightly, before bed, for a period of one month, and will be monitored for hypoglycemia events using a continuous glucose monitor.

"We are impressed both by the data generated to date and Zucara's ability to execute on its clinical development milestones," said Chris Garabedian, CEO of Xontogeny and Manager, PXV Fund for Perceptive Advisors. "We are proud to continue to support the development of ZT-01, which has the potential to become the first therapeutic designed to prevent hypoglycemia in people with T1D."

ZT-01 is designed to prevent potentially dangerous low blood sugar 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 restored by inhibiting SST with ZT-01, a first-in-class SST receptor 2 antagonist.

About Perceptive Xontogeny Venture Fund

Established in 2018, the Perceptive Xontogeny Venture Fund (PXV Fund) focuses purely on private investments in early stage life sciences companies. A primary source of investments for the PXV Fund are companies that are seeded, incubated, and/or actively managed by Xontogeny, a life sciences accelerator that provides experienced operational support to successfully and efficiently advance early stage companies. The PXV Fund is an affiliate of Perceptive Advisors, a New York City-based investment management firm founded in 1999 and focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information about Perceptive, visit www.perceptivelife.com.

About Zucara Therapeutics Inc.

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.