Investor Presentation First Nine Months of 2022
Novo NordiskⓇ
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Investor presentation First nine months of 2022
First efforts to combine Novo Nordisk and partner competencies
in cell therapies start with heart failure and Parkinson's disease
Heartseed: Phase 1/2 trial in patients with severe heart failure
TRANSCEND 1 and 2 trials to evaluate stem cells impact on
quality of life for people with moderate Parkinson's disease
10 patients with
•
Resting LVEF
≤40%
• NYHA cardiac
HS-001 low dose
function
classification
grade >II
HS-001 high dose
26-week
follow-up
52-week
follow-up
Screening
Japan
8 participants
USA, Sweden, UK
40 participants
Open-label transplant surgery or standard of care
Double-blinded transplant surgery or sham surgery, or
open-label standard of care
2 year primary
endpoint
5 year
follow-up
Objectives to evaluate:
• Safety of cardiomyocytes spheroids
Efficacy and dose-response
Feasibility of transplantation procedures
A follow-up phase 2 trial is planned to investigate further dose increase
and catheter delivery as route of administration
TRANSCEND 1: observational study of patients with moderate PD
aiming at identifying potential candidates to the interventional
TRANSCEND 2 trial
TRANSCEND 2: in combination with Lund University trial, a phase 1/2
trial investigating the treatment of Parkinson's disease
Primary endpoint: Number of treatment-emergent adverse events 2
years after dosing
PD: Parkinson's disease; LVEF: Left ventricular ejection fraction; NYHA: New York Heart AssociationView entire presentation