This presentation will discuss IRB/IEC approved research of an investigational medicine.
2
RVO real-worldanti-VEGF treatment outcomes fall short of clinical trial outcomes - more durable treatments are needed
# Eyes
Change (Letters)
BRVO
3,000
2,637
2,500
2,049
2,000
1,699
1,500
1,082
1,000
354
635
413
500
0
1
2
3
4
5
6
7
# Injections in first 6 months
20
15
13.1
10
8.0
# Eyes
Change (Letters)
CRVO
2,500
2,043
2,000
1,567
1,500
1,311
1,000
440
837
500
327
203
0
1
2
3
4
5
6
7
# Injections in first 6 months
20
14.4
15
10
Monthly dosing is difficult to achieve in clinical practice, where 72% of patients
received less than monthly dosing.
With currently available anti-VEGFs, treatment less often than monthly compromises vision outcomes in RVO
A less frequent therapy that
Mean VA
5
0
Mean VA
5
0
5.3
achieves comparable outcomes would be an important advance
1
2
3
4
5
6
7
# Injections in first 6 months
1 2 3 4 5 6 7
# Injections in first 6 months
Adapted from Ciulla T, et al. Br J Ophthalmol 2021;105:1696-1704.doi:10.1136/bjophthalmol-2020-317337. Represents 8,876 BRVO eyes, 6,737 CRVO eyes from Vestrum database. Mean 4.5 and 4.6 anti-VEGF injections over first 6
3
months (aflibercept, ranibizumab, or bevacizumab) in BRVO and CRVO, respectively. VA, Visual acuity. RVO, retinal vein occlusion. BRVO, branch retinal vein occlusion. CRVO, central retinal vein occlusion.
A novel class of biologics engineered for increased durability and efficacy
+=
ANTIBODY
BIOPOLYMER
CONJUGATE
lgG1 Anti-VEGF Antibody
Branched, Optically Clear,
Immunologically inert
High Molecular Weight
Phosphorylcholine Polymer
KSI-301 (tarcocimab tedromer) is an anti-VEGF ABC that blocks all VEGF-A isoforms
4
BEACON: Phase 3 non-inferiority study of tarcocimab tedromer every 2 months after only two loading doses vs aflibercept every 1 month in treatment-naïve RVO patients
Matched
Maintenance phase
PE
phase
Week
0
4
8
12
16
20
24
Tarcocimab tedromer 5 mg Q8W
(N~275)
Aflibercept 2 mg Q4W
(N~275)
Tarcocimab injection
Primary Endpoint:
Aflibercept injection
Sham injection
Mean change in BCVA at Week 24
Hierarchical testing for control of type 1 error: 1. Test non-inferiority in BRVO patients
2. Test non-inferiority in all RVO patients (BRVO+CRVO)
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Kodiak Sciences Inc. published this content on 30 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 September 2022 22:03:00 UTC.
Kodiak Sciences Inc. is a biopharmaceutical company. The Company has developed a new technology platform, the Antibody Biopolymer Conjugate (ABC) Platform, for retinal medicines. Its ABC Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies. Its lead investigational medicine, tarcocimab, is a novel anti-vascular endothelial growth factor (anti-VEGF) antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases, including diabetic retinopathy, the cause of blindness in working-age patients in the developed world, and wet age-related macular degeneration, the cause of blindness in elderly patients. Its second investigational medicine, KSI-501, is a bispecific antibody biopolymer conjugate targeting the pro-inflammatory cytokine interleukin-6 (IL-6) and VEGF. It is also developing a third investigational medicine, KSI-101, an unconjugated bispecific protein targeting IL-6 and VEGF.