Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UBX1325
foselutoclax · 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 |
Foselutoclax is being developed for diabetic macular edema, a retinal condition involving fluid accumulation in the macula of people with diabetes. It is an investigational small molecule given by intravitreal injection into the eye. It has not been approved for any use and remains in clinical development.
Foselutoclax is being developed by Unity Biotechnology, Inc., which trades on the Nasdaq under the ticker UBX. The company is the sponsor of the clinical program evaluating the drug in diabetic macular edema.
Foselutoclax is in Phase 2 clinical development for diabetic macular edema. It is an investigational therapy and is not FDA approved. The Phase 2 ASPIRE study has been completed, and no trials are currently listed as active.
The Phase 2 ASPIRE trial, registered as NCT06011798, evaluated repeat intravitreal injections of foselutoclax in patients with diabetic macular edema. The study enrolled 52 participants in the United States, was randomized, double blind, and used an active control. It is listed as completed.
Yes, foselutoclax is also known as UBX1325. Both names refer to the same investigational small molecule being developed by Unity Biotechnology for diabetic macular edema. The Phase 2 ASPIRE trial is registered under the UBX1325 designation.