Stiris Research Announces Positive Results from Zucara Therapeutics’ Phase 1b Hypoglycemic Clamp Trial

Stiris Research Inc. (“Stiris”), an entrepreneurial clinical trial management company focused on the management of Phase I-IIIB trials, announces the Phase 1b proof-of-concept trial demonstrated Zucara Therapeutics’ drug candidate, ZT-01’s ability to restore glucagon release in subjects with Type 1 Diabetes (“T1D”).

Data from 18 subjects that completed all three hypoglycemic challenge (clamp) procedures demonstrated that nearly 90% of subjects had a meaningful increase in glucagon following investigational product compared to placebo. Of the 18 subjects completing three clamps, 16 showed a greater than 10 pg/mL increase in glucagon higher than placebo following one or both doses of ZT-01. There were no serious adverse events observed.

“Such a positive study result is a reward in itself for the Project Manager and the entire study team, because we all have our “why” for which we work in this line of business. A study result that shows that a treatment may improve the quality of life not only for patients, but also for their families, is always a good motivator and acknowledgement that our work is indeed contributing to drug development.”  said Urszula Bartlomiejska, Project Manager, Stiris Research, Inc.

In people without diabetes, insulin secretion decreases while glucagon secretion increases to prevent hypoglycemia. However, in people with insulin-dependent diabetes, this response is dysregulated due to elevated secretion of pancreatic somatostatin (“SST”). 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.