Drug to Prevent Nighttime Lows Approved to Enter Clinical Trials
The FDA recently cleared a new experimental drug for type 1 diabetes to begin a phase 2 clinical trial. If approved, the drug would be the first therapy to specifically address low blood sugar at night.
Diabetes-focused life sciences company Zucara Therapeutics announced that it will begin a phase 2 clinical trial of its investigational new treatment to prevent nighttime hypoglycemia later this year.
The drug, an injectible medication currently known as ZT-01 will attempt to restore the body’s natural ability to respond to low blood sugar levels. ZT-01 is a first-in-class somatostatin receptor 2 antagonist – somatostatin is a hormone made by the pancreas that prevents the body from releasing glucagon. Researchers will evaluate the ability of the drug to blunt hypoglycemia caused by insulin in type 1 diabetes.
While insulin is the hormone that lowers blood glucose, glucagon, another hormone produced in the pancreas, counteracts insulin and raises glucose levels. Having type 1 diabetes may affect the body’s ability to release glucagon during a low; the goal of ZT-01 is to restore the body’s glucagon response, which could make it easier to recover from lows.
On April 19, Zucara announced it will begin its ZONE phase 2 clinical trial, with plans to enroll the first participant later this year. The trial will primarily look at rates of overnight hypoglycemia, as measured by a continuous glucose monitor, while participants take the drug every evening before bed for four weeks.
This phase 2 clinical trial follows positive results from the company’s earlier phase 1 study which included 18 participants with type 1 diabetes who received the treatment. Of these 18, 16 (89%) had a meaningful increase in glucagon production after being given ZT-01, with no serious health events during the trial.
In an announcement on the FDA clearance, Susan Peers, Zucara Therapeutics’ Director of Clinical and Regulatory Affairs, said “We are thrilled to have reached this important milestone and eager to initiate our phase 2 trial for the prevention of [nighttime] hypoglycemia, a frequent occurrence for people with insulin-dependent diabetes that is a significant cause of anxiety for both patients and their loved ones.”