Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AKB-9778 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AKB-9778 15 mg BID monotherapy | EXPERIMENTAL | Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months. |
| AKB-9778 15 mg BID + ranibizumab 0.3 mg | EXPERIMENTAL | Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months. |
| ranibizumab 0.3 mg monotherapy | ACTIVE_COMPARATOR | Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months. |
| Name | Type | Description |
|---|---|---|
| AKB-9778 | DRUG | - |
| ranibizumab | DRUG | - |
| Placebo | DRUG | - |
| Sham | DRUG | - |
The following is an abbreviated list of inclusion criteria: * Adults between 18 to 80 years of age, inclusive * Diagnosis of diabetes mellitus (type 1 or type 2) * Decrease in vision in the study eye determined to be primarily the result of DME * Definite retinal thickening due to diffuse DME invol...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
AKB-9778 is an investigational small molecule being studied for the treatment of diabetic macular edema (DME), a condition that causes vision loss in people with diabetes. It is currently in clinical development and has not been approved by regulatory authorities.
AKB-9778 is a Tie-2 activator, meaning it works by activating the Tie-2 receptor pathway. This mechanism is being investigated for its potential to reduce vascular leakage and inflammation associated with diabetic macular edema.
AKB-9778 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with diabetic macular edema.
AKB-9778 is in Phase 2 clinical development. It has completed a Phase 2 study, and it remains an investigational drug, meaning it has not yet received approval from the U.S. Food and Drug Administration or other regulatory bodies.
AKB-9778 has been studied in a Phase 2 clinical trial identified as NCT02050828, known as the TIME-2 Study. This trial enrolled 144 participants with diabetic macular edema in the United States and has been completed.
AKB-9778 is also known by its chemical name, and it is sometimes referred to as a Tie-2 activator. No alternative brand names have been established for this investigational compound in the available clinical trial information.