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UBX1325 50 μL

Phase 2

Neovascular Age-related Macular Degeneration | Small molecule | Ophthalmology |Unity Biotechnology, Inc.|Trials Updated: Aug 7, 2024

UBX1325 50 μL target and mechanism

ModalitySmall molecule

Also known as UBX1325 injection 50 μL

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

UBX1325 50 μL clinical trials

UBX1325 50 μL · 1 trial · 1 indication

Phase 2 1
NCT05275205Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)Neovascular Age-related Macular Degeneration
COMPLETED51 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
Neovascular Age-related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Through 24 weeks

Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24

Secondary Endpoints

Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Through 48 weeks
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Through 48 weeks
Adverse Events (Safety)
Through 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UBX1325EXPERIMENTAL -
Aflibercept (EYLEA ®)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
UBX1325 injection 50 μLDRUGPatients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
EYLEA® (aflibercept) Injection 2 mg (0.05mL)DRUGPatients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Patients aged ≥50 years. * Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1 * BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 ...

Countries:United States
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Frequently asked questions about UBX1325 50 μL

What is UBX1325 50 μL used for?

UBX1325 50 μL is an investigational small molecule being studied for the treatment of neovascular age-related macular degeneration, an eye condition in which abnormal blood vessels grow under the retina. It is administered as an injection and is being developed by Unity Biotechnology, Inc. (ticker UBX).

Who makes UBX1325 50 μL?

UBX1325 50 μL is being developed by Unity Biotechnology, Inc., which trades on the Nasdaq under the ticker UBX. Unity Biotechnology is the sponsor of the clinical program evaluating this small molecule injection in patients with neovascular age-related macular degeneration.

What phase is UBX1325 50 μL in?

UBX1325 50 μL is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 program includes one completed trial, and no trials of this asset are currently listed as active.

What clinical trials is UBX1325 50 μL in?

UBX1325 50 μL has been evaluated in the Phase 2 ENVISION study, registered as NCT05275205. The trial enrolled 51 patients with neovascular age-related macular degeneration across sites in the United States, was randomized, double-blind, and active-controlled, and is now completed.

Is UBX1325 50 μL the same as UBX1325 injection 50 μL?

Yes. UBX1325 50 μL and UBX1325 injection 50 μL refer to the same investigational product from Unity Biotechnology, Inc. The 50 μL designation describes the injected volume of the small molecule formulation studied in patients with neovascular age-related macular degeneration.