Investor Presentaiton
IBI-306 (PCSK9) Development Plan Overview
Data of SAD and MAD was disclosed in ESC, Aug 2020
IBI-306 Development Program Overview
The point estimate and 95% confidence interval for the difference in percent reduction from baseline in LDL-C at 12 weeks
for each dose group compared with placebo are as follows:
Phase 1: Percentage Change from Baseline in LDL-C Levels
•
75 mg Q2W: -58.91% (-76.54%, -41.28%)
•
•
140 mg Q2W: -51.89% (-70.09%, -33.68%)
300 mg Q4W: -57.73% (-72.89%, -42.57%)
420 mg Q4W: -69.85% (-84.43%, -55.26%)
450 mg Q6W: -59.95% (-78.81%, -41.10%)
600 mg Q6W: -54.11% (-73.78%, -34.44%)
The safety profile of IBI-306 in MAD is consistent
with that in SAD
Incidence of TEAE between IBI-306 and
placebo group is similar.
•
No SAE is reported.
In SAD/MAD studies, IBI-306
demonstrated good efficacy/safety
profile, and the potential to be
developed as long-acting PCSK9
inhibitor.
LDL-C的平均相对基线变化率(%)
低密度脂蛋白胆固醇(mmol/L)
相对基线变化率(%) (线性)
40-
20-
10
-20-
-40
-60-
-80-
给药后4小时7 11 15
20
0.
-20-
-40-
-60-
-80-
57
相对给药时间(天)
25 mg SC
75 mg SC
75 mg IV
150 mg SC
-3--300 mg SC
450 mg SC
-450 mg IV
600 mg SC
安慰剂合计
Phase 2: Percentage Change from Baseline in LDL-C Levels
71
85
D1, -1H
D15, -1H
D29, -1H
D43, -1H
D57, -1H
D71, -1H
D85
D99
相对给药时间(天)
75 mg Q2W
420 mg Q4W
140 mg Q2W
450 mg Q6W
300 mg Q4W
600 mg Q6W
安慰剂合计
Clinical
progress
2021 plan
.
HeFH
Completed patient enrolment for Phase 3 trial for HeFH in 2020
HOFH
Kept patient enrolment for pivotal Phase 2 trial during 2020
In Jan 2021, completed patient enrolment for Phase 3 in China
for Non-FH
Plan to have data read out for Phase 3 study of IBI-306 in HeFH
in 2021
Comparison with other PCSK9 in China
Imported PCSK9i
Amgen, Sanofi
IBI-306
Innovent
Status
Ph3
On market
HOFH
HoFH
Indications
HeFH
Non-HF
Duration
Efficacy
Safety
Patient Size in China
Q4W or Q6W
50-70% LDL-C decreased
1200
HeFH
Non-FH
Q2W or Q4W
50-70% LDL-C decreased
Comparable with each other
300-500
Other Domestic PCSK9i
Ph1/Ph2/Ph3
HoFH
Mixed Dyslipidema
Q2W or Q4W
Not disclosed
Not disclosed
600-900
Compared with other PCSK9 inhibitors, IBI-306 has long-acting potential, good efficacy comparable to imported brands, and
fastest clinical progress among domestic PCSK9 in China.
Innovent
Confidential
Copyright©2021 Innovent Biologics
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