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AKB-9778 · 1 trial · 1 indication
Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12
| Arm | Type | Description |
|---|---|---|
| AKB-9778 15mg Daily | EXPERIMENTAL | AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo |
| AKB-9778 15mg Twice Daily | EXPERIMENTAL | AKB-9778 15 mg (BID) |
| Placebo Twice Daily | PLACEBO_COMPARATOR | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) |
| Name | Type | Description |
|---|---|---|
| AKB-9778 | DRUG | Subcutaneous AKB-9778 15mg |
| Placebo | DRUG | Subcutaneous Placebo |
Key Inclusion Criteria: * Adults 18 through 80 years of age (inclusive) * Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive) * No evidence of central involved diabetic macular edema * ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better) Key Exclusi...
AKB-9778, also known as razuprotafib, is an investigational small molecule being studied for the treatment of nonproliferative diabetic retinopathy (NPDR), a condition affecting the retina in people with diabetes. It is being developed by EyePoint, Inc. (EYPT) and is currently in Phase 2 clinical development.
AKB-9778 is a Tie 2 activator. It works by activating the Tie 2 receptor, which plays a role in vascular stability and may help address the underlying vascular abnormalities associated with nonproliferative diabetic retinopathy. This mechanism is being evaluated in clinical trials for its potential to treat NPDR.
AKB-9778 is being developed by EyePoint, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EYPT. The company is conducting clinical research on this investigational therapy for nonproliferative diabetic retinopathy.
AKB-9778 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating nonproliferative diabetic retinopathy.
AKB-9778 has been studied in a Phase 2 clinical trial with the identifier NCT03197870, known as the TIME-2b Study. This randomized, double-blind, placebo-controlled trial enrolled 167 participants with nonproliferative diabetic retinopathy in the United States and has been completed.
Yes, AKB-9778 is also known as razuprotafib. The TIME-2b clinical trial, identified as NCT03197870, refers to the drug as both AKB-9778 and razuprotafib, confirming that these names refer to the same investigational therapy for nonproliferative diabetic retinopathy.