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UBX1325 · 2 trials · 3 indications
The systemic safety and tolerability is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs) by System organ class Preferred Term.
Ocular Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs). Ocular TEAEs consisted of progression of disease or were related to the IVT injection component of the UBX1325 drug administration process
| Arm | Type | Description |
|---|---|---|
| UBX1325 | EXPERIMENTAL | - |
| Sham Control | SHAM_COMPARATOR | - |
| Treatment with UBX1325 | EXPERIMENTAL | UBX1325, single intravitreal injection, ascending dose |
| Name | Type | Description |
|---|---|---|
| UBX1325 | DRUG | Patients will be administered a single 50 μL UBX1325 IVT injection |
| Sham | OTHER | Sham procedure |
Inclusion Criteria: * Patients aged ≥ 18 years. * Diabetic retinopathy patients (nonproliferative (NPDR) and proliferative (PDR)) with DME (ETDRS-DRSS Score at 65C \[or DR severity level of 8\]or less severe as determined by a Central Reading Center), who had at least 2 anti-VEGF intravitreal (IVT)...
| 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 |
UBX1325 is an investigational small molecule being developed for diabetic macular edema (DME), a condition that causes vision loss due to fluid buildup in the macula. It is also being studied in neovascular age-related macular degeneration. UBX1325 is in clinical development and is not yet approved by regulatory authorities.
UBX1325 is a small molecule designed to target senescent cells, which are cells that have stopped dividing and can contribute to disease. By targeting these cells, UBX1325 aims to address the underlying pathology of diabetic macular edema. The specific molecular target has not been disclosed in available information.
UBX1325 is being developed by Unity Biotechnology, Inc., a company traded on the NASDAQ under the ticker symbol UBX. Unity Biotechnology focuses on developing therapies that target senescent cells to treat age-related diseases, including ophthalmologic conditions like diabetic macular edema.
UBX1325 has completed a Phase 1 clinical trial and a Phase 2 clinical trial. The Phase 1 trial (NCT04537884) evaluated safety and tolerability, while the Phase 2 trial (NCT04857996), known as BEHOLD, assessed safety, tolerability, and evidence of activity in patients with diabetic macular edema. Both trials are completed.
UBX1325 has been studied in two completed clinical trials. The first, NCT04537884, was a Phase 1 safety and tolerability study in patients with diabetic macular edema or neovascular age-related macular degeneration. The second, NCT04857996 (BEHOLD), was a Phase 2 study in patients with diabetic macular edema, conducted in the United States and Canada.
UBX1325 is the primary name for this investigational drug. No alternative names have been reported in available clinical trial information. It is a small molecule developed by Unity Biotechnology, and it is distinct from other therapies for diabetic macular edema, such as anti-VEGF agents, due to its senolytic mechanism of action.