Investor Presentation First Nine Months of 2023
Novo NordiskⓇ
110
Investor presentation
First nine months of 2023
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