Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tarcocimab tedromer, KSI-301
Tarcocimab · 4 trials · 4 indications
Mean change in BCVA from Day 1 to Year 1
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
| Arm | Type | Description |
|---|---|---|
| Tarcocimab tedromer 5 mg (KSI-301) | EXPERIMENTAL | Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks. |
| Tabirafusp tedromer 5 mg (KSI-501) | EXPERIMENTAL | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing |
| Tarcocimab 5 mg (Treatment Group A) | EXPERIMENTAL | Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. |
| Treatment Group B | SHAM_COMPARATOR | Sham injection on the same schedule as Treatment Group A |
| KSI-301 (Treatment Group A) | EXPERIMENTAL | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. |
| Aflibercept (Treatment Group B) | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered. |
| KSI-301 (Arm A) | EXPERIMENTAL | Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
| Aflibercept (Arm B) | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
| Name | Type | Description |
|---|---|---|
| Tarcocimab tedromer | DRUG | Intravitreal injection |
| Tabirafusp tedromer | DRUG | Intravitreal injection |
| Aflibercept | DRUG | Intravitreal injection |
| Tarcocimab | DRUG | Intravitreal injection |
| Sham injection | OTHER | The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study. |
| KSI-301 | DRUG | Intravitreal Injection |
| Sham Procedure | OTHER | The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
Inclusion Criteria: * Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the ...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ocular Therapeutix Inc | OCUL | 1 | PHASE3 | OTX-TKI |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | Surabgene Lomparvovec |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| Jaeb Center for Health Research | RHHBY | 3 | PHASE3 | Faricimab, RO7663498 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Tarcocimab is an investigational monoclonal antibody being developed for the treatment of diabetic retinopathy. It is designed to be administered as an intravitreal injection for patients with this retinal condition. Kodiak Sciences Inc. is evaluating tarcocimab in a Phase 3 clinical program, and the drug has not been approved by the FDA for any indication.
Tarcocimab is being developed by Kodiak Sciences Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol KOD. Kodiak Sciences is responsible for the clinical development of tarcocimab, including the Phase 3 trial in diabetic retinopathy.
Tarcocimab is in Phase 3 clinical development. The Phase 3 study in diabetic retinopathy has been completed, and the drug remains investigational. It has not been approved by the FDA for any indication.
Tarcocimab has been evaluated in a Phase 3 clinical trial, NCT06270836, titled A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy. The trial enrolled 255 participants, was randomized, double-blind, and sham-controlled, and has been completed. It was conducted in the United States and Puerto Rico.
Tarcocimab tedromer is the full name used for tarcocimab in its clinical trial, NCT06270836. Tarcocimab is the shorter name for the same investigational monoclonal antibody being developed by Kodiak Sciences Inc. for diabetic retinopathy.