Corporate Presentation
ZEAL&
ZEALAND PHARMA
Rare diseases
CHI
Three Phase 3 trials form the basis of our NDA
submission to the US FDA for dasiglucagon in CHI
Trial 17103: Dasiglucagon significantly
reduced the requirement for IV glucose
in a hospital setting
IV Glucose Infusion Rate
Trial 17109: Dasiglucagon reduced time in
hypoglycemia by ~50% and hypoglycemic
events by 37-40% in a homecare setting
Hypoglycemia events per week
detected by CGM*
Part 2:
21-days open-
label treatment²
Part 1:
Placebo control,
crossover x 48 hours¹
IV Glucose Infusion Rate
(mg/kg/min)
15
10
2505
15.7
p=0.0037
9.4
4.3
0
Baseline Placebo Dasi
10 of 12 patients weaned off IV
glucose >12 hours
7 patients weaned off IV glucose
without need for pancreatectomy
60
50
Standard of Care (SoC)
40
Dasiglucagon + SoC in
all participants
Events / week (<70 mg/dl)
IN WAS
30
20
10
Dasiglucagon + SoC
0
T
T
BL
1
2
3 4
5
7
8
Weeks
*Primary endpoint comparing rates of hypoglycemia detected by SMPG
demonstrated no difference between dasiglucagon and SoC
CGM = continuous glucose monitoring; SMPG = self-measured plasma glucose
Assessed as generally well tolerated in both trials
Skin reactions and gastrointestinal disturbances most frequently reported adverse events
42 of 44 participants continued into long-term extension trial 17106
17103 Phase 3 clinical trial enrolled patients aged 7 days to 12 months, who were newly diagnosed and dependent on IV glucose in hospital setting: https://clinicaltrials.gov/ct2/show/NCT04172441
17109 Phase 3 clinical trial enrolled children aged 3 months to 12 years being treated with standard of care (+/- surgery) with persistent hypoglycemia: https://clinicaltrials.gov/ct2/show/NCT03777176
17106 is an open label long-term safety study that enrolled 17109 and 17103 participants with ongoing positive benefit / risk aged >1 month: https://clinicaltrials.gov/ct2/show/NCT03941236
1 De Leon et al. European Society for Paediatric Endocrinology (ESPE), September 2022; 2 Banerjee et al. ESPE, September 2022; ³Thornton et al. Pediatric Endocrine Society, April 2022
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