Zealand Pharma A/S announced that clinical results from the two-part Phase 3 trial of dasiglucagon for the treatment of congenital hyperinsulinism (CHI) in newborns and infants up to 12 months of age were presented at the 60th annual European Society for Paediatric Endocrinology (ESPE) meeting, held in Rome, September 15-17, 2022. Topline results from Part 1 of the trial were previously announced in May 2022 (Company Announcement No. 22 /2022).

The abstracts of the oral presentations are available at eurospe.org and the data are summarized as follows: Title: Dasiglucagon Significantly Reduces Requirement for Intravenous Glucose in Children with Congenital Hyperinsulinism ages 7 Days to 12 Months Authors: Diva D. De Leon, Indraneel Banerjee, David M. Kendall, Sune Birch, Eva Bøge, Jelena Ivkovic & Paul S. Thornton Presentation Highlights: In Part 1 of the Phase 3 trial, dasiglucagon significantly reduced the requirement for intravenous (IV) glucose to maintain glycemia in neonates and infants with CHI and reduced glucose requirements to levels that potentially allow for discontinuation of IV glucose support. -- Dasiglucacagon significantly reduced the mean IV glucose infusion rate (GIR) in the last 12 hours of the 48 hour treatment period by 55% as compared to placebo (4.3 mg/kg/min for dasiglucagon and 9.4 mg/kg/min for placebo with a treatment difference of 5.2 mg/kg/min; p=0.0037). Dasiglucagon also reduced GIR over the entire 48-hour treatment period by 3.5 mg/kg/min compared to placebo (p=0.0107).

-- Dasiglucagon treatment resulted in a reduction of 31 g/day in total carbohydrate intake (IV and gastric) compared to placebo (107 g/day for dasiglucagon vs 138 g/day for placebo; p = 0.024), a 22% reduction in carbohydrate calories. -- Dasiglucagon was observed to be well tolerated in Part 1 of the trial, with skin reactions and gastrointestinal disturbances as the most frequently reported adverse events (no serious adverse events reported). itle: Dasasiglucagon Treatment Over 21 days in Infants with Congenital Hyperinsunism Results in Glycaemic Stabability and Reduces Requirement for Intravenous Glucose Authors: Indraneel Banerjee, Diva D. De Leon, David M. Kendall, Sune Birch, Eva Bøge, Jelena Ivkovic & Paul S. Thornton Presentation Highlights: In the 21-day open-label Part 2 of the Phase 3 trial, continuous subcutaneous infusion of dasiglucagon in infants with CHI reduced IV glucose requirements, time in hypoglycaemia and enabled discontinuation of IV glucose in most infants, obviating the need for subtotal pancreatectomy for glycaemic stability.

Dasigcacagon enabled reduction and either periodic or permanent discontinuation of IV glucose infusion in 10 out of 12 infants. -- Seven infants, who did not require pancreatectomy, were completely weaned off IV glucose at the completion of the trial. -- During the 21-day treatment with dasiglucagon, continuous glucose monitoring (CGM) measures of hypoglycaemia trended lower with median time <70 mg/dL reduced from 7.0% to 5.2% and <54 mg/dL reduced from 1.9% to 0.88%.

There was no increase in hyperglycaemia. -- The safety profile of dasiglucagon in Part 2 was consistent with Part 1, with no adverse event requiring discontinuation of treatment and no serious adverse events reported.