Zealand Reports Results of Dasiglucagon in P-III (17103) Trial for the Treatment of Congenital Hyperinsulinism in Pediatric Patients
- The 2nd P-III (17103) trial evaluates the potential for chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in 12 pediatric patients aged 7 days to 12mos. with CHI. 11 patients continue into the long-term safety extension study
- The trial met the 1EPs i.e., the therapy showed a reduction in mean IV GIR @12hr. (4.3mg/kg/min for dasiglucagon & 9.4mg/kg/min for PBO), 55% reduction of IV glucose requirement, was well tolerated & safety profile was consistent with previous P-III trial in children aged 3mos. to 12yrs.
- The company plans to submit the NDA to the US FDA at the end of 2022. Dasiglucagon is a glucagon analog that is stable in an aq. solution & suitable for chronic pump use
Ref: Globenewswire | Image: Zealand Pharma
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