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Also known as foselutoclax
UBX1325 · 3 trials · 11 indications
Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
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 |
|---|---|---|
| Anti-VEGF control arm | ACTIVE_COMPARATOR | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1. |
| foselutoclax arm | EXPERIMENTAL | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1. |
| UBX1325 | EXPERIMENTAL | - |
| Sham Control | SHAM_COMPARATOR | - |
| Treatment with UBX1325 | EXPERIMENTAL | UBX1325, single intravitreal injection, ascending dose |
| Name | Type | Description |
|---|---|---|
| Aflibercept | DRUG | Anti-VEGF control |
| foselutoclax | DRUG | Experimental drug |
| UBX1325 | DRUG | Patients will be administered a single 50 μL UBX1325 IVT injection |
| Sham | OTHER | Sham procedure |
Inclusion Criteria: * Patients aged ≥18 years. * Patients with nonproliferative DR and DME * Center-involved DME with Central Subfield Thickness (CST) ≥325-900 μm * BCVA in the SE (most affected) of 70 to 30 ETDRS letters (equivalent to 20/40 to 20/250 on the Snellen chart) Exclusion Criteria: * ...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
UBX1325 is being developed for the treatment of diabetic macular edema, an eye condition in which fluid accumulates in the retina of people with diabetes. It is an investigational small molecule studied in adults with diabetic macular edema, and it has also been evaluated in patients with neovascular age-related macular degeneration.
UBX1325 is being developed by Unity Biotechnology, Inc., which trades on the Nasdaq under the ticker UBX. The company has sponsored the clinical studies of UBX1325 in diabetic macular edema conducted in the United States and Canada.
UBX1325 has completed a Phase 2 clinical trial in diabetic macular edema and a Phase 1 trial in diabetic macular edema and neovascular age-related macular degeneration. It is an investigational therapy and is not approved by the FDA. No trials of UBX1325 are currently active.
UBX1325 has been studied in two completed trials. The Phase 2 BEHOLD study, NCT04857996, enrolled 65 patients with diabetic macular edema in the United States and Canada. The Phase 1 study NCT04537884 enrolled 19 patients with diabetic macular edema or neovascular age-related macular degeneration in the United States.
Both UBX1325 trials were randomized, double-blind, and sham-controlled, with a combined enrollment of 84 patients. The Phase 2 BEHOLD trial enrolled adults aged 18 and older, while the Phase 1 trial enrolled patients aged 50 and older. Both studies are listed as completed.