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UBX1325 50 μL

Phase 2

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

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

Clinical trial landscape

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 used for?

UBX1325 is an investigational small molecule being developed for the treatment of neovascular age-related macular degeneration, a condition that causes abnormal blood vessel growth and vision loss. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes UBX1325?

UBX1325 is being developed by Unity Biotechnology, Inc., a company traded on the stock exchange under the ticker symbol UBX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for neovascular age-related macular degeneration.

What phase is UBX1325 in?

UBX1325 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. A Phase 2 clinical trial has been completed to evaluate its safety, tolerability, and efficacy in patients with neovascular age-related macular degeneration.

What clinical trials is UBX1325 in?

UBX1325 has been studied in one completed Phase 2 clinical trial with the identifier NCT05275205, known as the ENVISION study. This trial enrolled 51 participants in the United States and evaluated the drug in patients with neovascular age-related macular degeneration.

Is UBX1325 the same as any other drug?

UBX1325 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being studied specifically for neovascular age-related macular degeneration and is not known to be marketed under any other brand name.