Zealand Pharma A/S ZEAL has announced topline results from its second Phase 3 trial of dasiglucagon in pediatric patients with congenital hyperinsulinism (CHI), a condition in which individuals have abnormally high levels of insulin.
- Dasiglucagon met the trial's primary endpoint by demonstrating a statistically significant difference between treatment arms.
- The baseline intravenous glucose infusion rate (IV GIR) was 15.7 mg/kg/min. Dasiglucagon treatment resulted in a significant reduction in the mean IV GIR versus placebo as measured during the last 12 hours of each treatment period (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).
- Zealand Pharma will engage with the FDA to discuss the marketing application submission anticipated by the end of 2022. Dasiglucagon has the potential to become the first medicine explicitly developed for this debilitating, ultra-rare disease in over three decades.
- Price Action: ZEAL shares are up 20.7% at $14.12 during the market session on the last check Thursday.
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