Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)
- Dasiglucagon met the primary endpoint with statistical significance - reducing the requirement for intravenous glucose by 55% compared to placebo in this pediatric patient population (ages 7 days to 12 months) when compared to placebo.
- Dasiglucagon treatment was assessed as well-tolerated in this study and 11 out of 12 patients are continuing into the long-term safety extension study.
- These data, together with data from a previously reported Phase 3 study in older children with CHI, are expected to form the basis of a new drug application (NDA) for dasiglucagon treatment in the management of CHI, with the U.S. Food and Drug Administration. Submission is anticipated by end of 2022.
Copenhagen, DK and Boston, MA, U.S. May 19, 2022 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced positive top-line results from its second Phase 3 clinical trial of dasiglucagon in pediatric patients with congenital hyperinsulinism (CHI). The Phase 3 program for dasiglucagon constitutes the largest clinical development program ever conducted in CHI.
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