Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — Technical Presentation (2022)
16 slides from Zealand Pharma A/S's technical presentation, 2022
Slide 1: Dapiglutide, a once-weekly GLP-1R/GLP-2R dual agonist, safe and well tolerated
Dapiglutide, a once-weekly GLP-1R/ GLP-2R dual agonist, was safe and well tolerated and showed dose- dependent body weight loss over 4 weeks in healthy subjects Minna Brændholt Olsen1, Ulrike Hövelmann2, Jon Griffin1, Kim Mark Knudsen1, Per-Olof Eriksson1, Mikkel Askjær Agersnap1 1Zealand Pharma A
Slide 2: Presenter disclosure
Presenter disclosure Mikkel Askjær Agersnap Employee at Zealand Pharma A/S Stock/shareholder: Zealand Pharma A/S
Slide 3: Photography allowed
Photography allowed You may take photos of this presentation. Please be considerate of others in the session.
Slide 4: Multiple ascending dose study
Multiple ascending dose study Design Objectives N=40 3.5/6.0 Primary objective 7:3 mg • Evaluate safety and tolerability 3.5mg Cohort 4 2.25mg Cohort 3 Secondary objectives • Investigate immunogenicity 1.0mg Cohort 2 • Investigate pharmacokinetics Cohort 1 • Assess pharmacodynamics ➢ P-Acetaminophen
Slide 5: All demographics were balanced across cohorts of healthy subjects
All demographics were balanced across cohorts of healthy subjects Total, n=40 Mean (SD) Age, years 34 (8.8) Sex, number M/F 39/1 Body weight, kg 78.3 (8.2) BMI 24.6 (2.3) All 40 randomized subjects received four doses and completed the trial
Slide 6: Pharmacokinetics of dapiglutide
Pharmacokinetics of dapiglutide Conclusions ✓ Dose proportionality shown Dapiglutide concentration (nmol/L) ➢ For AUC0-t and Cmax ✓ Once weekly profile ➢ Half-life: 123-129 h ✓ At steady state after 4th dose
Slide 7: Safety
Safety • No severe adverse events • No serious adverse events (SAEs) • No withdrawals due to AEs • No anti-drug antibodies
Slide 8: Incidence of most frequent treatment-emergent adverse events
Incidence of most frequent treatment-emergent adverse events Dapiglutide Dapiglutide Dapiglutide Dapiglutide Placebo 1.00 mg 2.25 mg 3.5 mg 3.5/6.0 mg (N=12) (N=7) (N=7) (N=7) (N=7) Only SOCs with a total of ≥3 subjects are shown
Slide 9: Incidence of most frequent treatment-emergent adverse events
Incidence of most frequent treatment-emergent adverse events Dapiglutide Dapiglutide Dapiglutide Dapiglutide Placebo 1.00 mg 2.25 mg 3.5 mg 3.5/6.0 mg (N=12) (N=7) (N=7) (N=7) (N=7) One subject in each column 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 10 11 12 Only SOC
Slide 10: Incidence of most frequent treatment-emergent adverse events
Incidence of most frequent treatment-emergent adverse events Dapiglutide Dapiglutide Dapiglutide Dapiglutide Placebo 1.00 mg 2.25 mg 3.5 mg 3.5/6.0 mg (N=12) (N=7) (N=7) (N=7) (N=7) One subject in each column Overall incidence Only SOCs with a total of ≥3 subjects are shown
Slide 11: Incidence of most frequent treatment-emergent adverse events
Incidence of most frequent treatment-emergent adverse events Dapiglutide Dapiglutide Dapiglutide Dapiglutide Placebo 1.00 mg 2.25 mg 3.5 mg 3.5/6.0 mg (N=12) (N=7) (N=7) (N=7) (N=7) One subject in each column Overall incidence Decreased appetite Gastrointestinal Nervous system disorders General diso
Slide 12: Dose-dependent body weight loss
Dose-dependent body weight loss Dapiglutide Weight at baseline Mean 78 kg Range 62 – 95 kg 2.3% 4.3%
Slide 13: Reduced meal consumption
Reduced meal consumption Mixed meal test Standard meals Dapiglutide
Slide 14: Dose-dependent reductions in gastric emptying
Dose-dependent reductions in gastric emptying Mixed test meal Change from baseline in AUC 0-4 hours Acetaminophen value (µg/mL) Acetaminophen value (µg/mL) Dapiglutide
Slide 15: Dose-dependent reductions in insulin and glucose
Dose-dependent reductions in insulin and glucose Mixed test meal Glucose Insulin
Slide 16: Summary points and conclusion
Summary points and conclusion Summary ➢ Dapiglutide was safe and well-tolerated in healthy study subjects ➢ Dose dependent body weight loss up to a mean 4.3% in 4 weeks in healthy subjects ➢ Predictable PK profile with a half-life consistent with once-weekly dosing ➢ Dose dependent reductions in gas