Pharma Update
Zilebesiran: Comprehensive development program ongoing
Positive Ph II (KARDIA-1) results to be presented at upcoming conference
Ph II (KARDIA-2) trial design¹
Alnylam Roche
PHARMACEUTICALS
Clinical development program
Ph II (KARDIA-1) topline results
Olmesartan
Oral QD
R
1:1
Primary endpoint
Phl
Ph II
Ph III
24h mean SBP change at month 3
R
Amlodipine
Oral QD
R
12 M
OLE*
Secondary endpoints
KARDIA-1
1:1
N=800
1:1:1
KARDIA-2
Data early 2024
24h mean SBP change at month 6
Indapamide
Oral QD
R
4 week run-
in
M
M
M
1:1
0
3
6
KARDIA-3
To initiate in 2024
Primary endpoint:
Office SBP change at month 3 & 6
24h mean SBP change at M3
CVOT based on
KARDIA-3
0/A/I QD + Zilebesiran 600 mg SC Q6M
0/A/I QD + Placebo SC Q6M
• Ph II (KARDIA-1): Monotherapy in mild/moderate hypertension; met all primary and key secondary
endpoints; data to be presented at upcoming scientific conference
• Ph II (KARDIA-2): Add-on to one SoC in uncontrolled hypertension; data expected early 2024
⚫ Ph II (KARDIA-3): Add-on to SoC (2+ treatments) in uncontrolled hypertension with high CV risk; to be
initiated in 2024
⚫ Ph III: CV outcomes (MACE-type endpoint) in uncontrolled hypertension with high CV risk
• Ph II (KARDIA-2) fully enrolled and ongoing
Ph II (KARDIA-3) results will inform pivotal Ph III
trial design
• Ph Ill to deliver robust label with CV outcomes
benefits at launch
• Potential for expansion to other CV indications
(e.g. heart failure)
*Patients in the OLE phase receive zilebesiran 600 mg SC Q6M; ¹NCT05103332; SBP-systolic blood pressure; SoC-standard of care; CV-cardiovascular; CVOT-CV outcomes trial; MACE=major adverse cardiovascular events;
R=randomization; M=month; SC=subcutaneous; Q6M-every 6 months; QD=daily; OLE=open label extension; O=olmesartan; A=amlodipine; l=indapamide; zilebesiran in partnership with Alnylam Pharmaceuticals
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