On February 15, 2022, biotechnology company Zealand Pharma A/S (“Zealand”) announced that its Phase 3 1703 clinical trial evaluating dasiglucagon for congenital hyperinsulinism (CHI) had reached full enrollment. Within this study, researchers will explore the treatment for those with CHI who are 1 year old or younger. 

Dasiglucagon

According to Zealand, the current standards-of-care for congenital hyperinsulinism are relatively ineffective. In fact, the company shares, researchers estimate that fewer than 33% of infants and 66% of older children respond to current therapeutic interventions. Thus, dasiglucagon could fill an unmet need within this community – and help improve patient outcomes.

Dasiglucagon is a glucagon analog which can be used via an infusion pump. The treatment has received Orphan Drug designation in both the United States and Europe. Additionally, Zealand is working with DEKA, which sources the pumps used to administer the dasiglucagon. 

Within this clinical trial, researchers seek to identify:

• The safety, efficacy, and tolerability of infusion-administered dasiglucagon
• How well dasiglucagon prevents hypoglycemia
• Whether this treatment could reduce the need for patients to undergo pancreatectomies
• How dasiglucagon could reduce hospitalizations or near-constant feeding needs

What is Congenital Hyperinsulinism (CHI)?

Altogether, there are eight different forms of congenital hyperinsulinism (CHI), a condition which causes severe and persistent hypoglycemia in infants and children. An estimated 1 in every 25,000-50,000 infants is born with CHI. While some forms of CHI result from genetic mutations, other forms may be caused by premature birth or a mother’s unmanaged diabetes. Regardless, CHI causes the pancreas to secrete too much insulin. In turn, this causes low blood sugar and related health impacts. Patients may experience frequent or recurring hypoglycemic episodes. Without intervention, these can be dangerous (causing seizures or comas) or even fatal. 

Symptoms associated with CHI include:

• Lethargy
• Excessive hunger
• Irritability
• Rapid heart rate
• Sleepiness or intense fatigue
• Confusion
• General bodily weakness or shakiness