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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 is being developed for nonproliferative diabetic retinopathy, an eye condition in people with diabetes. It is an investigational small molecule studied in a Phase 2 clinical trial. It has not been approved for commercial use, and development has focused on the ophthalmology therapeutic area.
AKB-9778 targets VE-PTP, also known as vascular endothelial protein tyrosine phosphatase. VE-PTP is a protein target, and the drug is designed as a small molecule that acts on this pathway. Targeting VE-PTP is intended to influence Tie 2 signaling relevant to retinal blood vessel health.
AKB-9778 is being developed by EyePoint, Inc., which trades under the ticker EYPT. The company is the sponsor of the clinical program evaluating the drug in nonproliferative diabetic retinopathy. EyePoint is an ophthalmology-focused biopharmaceutical company.
AKB-9778 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program in nonproliferative diabetic retinopathy has completed its single registered trial, and no trials are currently listed as active.
AKB-9778 has been studied in one clinical trial, NCT03197870, known as the TIME-2b study. It was a Phase 2, randomized, double-blind, placebo-controlled trial in patients with nonproliferative diabetic retinopathy. The trial enrolled 167 participants in the United States and has completed.
Yes, AKB-9778 is also known as razuprotafib. The Phase 2 TIME-2b study, registered as NCT03197870, refers to the drug as AKB-9778 (razuprotafib), a Tie 2 activator. Both names refer to the same investigational small molecule being developed by EyePoint, Inc. for nonproliferative diabetic retinopathy.