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GEM103

Phase 1

Dry Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Disc Medicine, Inc.|Last Updated: Feb 11, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

GEM103 · 1 trial · 5 indications

Phase 1 1
NCT04246866First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular DegenerationDry Age-related Macular Degeneration
COMPLETED12 Analytics
PHASE1COMPLETED
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
Dry Age-related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of AEs/SAEs following drug administration
Up to 8 Weeks

Secondary Endpoints

GEM103 concentrations in ocular fluids
Up to 8 Weeks
Changes in complement factor levels compared to baseline after drug administration
Up to 8 Weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose 1EXPERIMENTALA single dose of GEM103 will be administered via intravitreal injection. This arm will be the lowest dose of GEM103
Dose 2EXPERIMENTALA single dose of GEM103 will be administered via intravitreal injection. This arm will be the medium dose of GEM103
Dose 3EXPERIMENTALA single dose of GEM103 will be administered via intravitreal injection. This arm will be a higher dose of GEM103
Dose 4EXPERIMENTALA single dose of GEM103 will be administered via intravitreal injection. This arm will be the highest (extension) dose of GEM103

Interventions

NameTypeDescription
GEM103BIOLOGICALGEM103
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. At least 50 years old at the time of signed informed consent 2. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure 3. Best corrected visual acuity (BCVA...

Countries:United States
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Frequently asked questions about GEM103

What is GEM103 used for?

GEM103 is an investigational monoclonal antibody being developed for dry age-related macular degeneration, specifically for geographic atrophy secondary to dry AMD. It is designed to address retinal degeneration in patients with this condition. The drug is currently in clinical development and is not yet approved by regulatory authorities.

What does GEM103 target?

GEM103 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its potential to treat geographic atrophy in dry age-related macular degeneration, a condition characterized by retinal degeneration.

Who is developing GEM103?

GEM103 is being developed by Disc Medicine, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IRON. Disc Medicine is conducting clinical research to evaluate the safety and tolerability of GEM103 in patients with dry age-related macular degeneration.

What phase is GEM103 in?

GEM103 is in Phase 1 clinical development. A first-in-human study has been completed to evaluate its safety and tolerability in patients with geographic atrophy secondary to dry age-related macular degeneration. The drug remains investigational and has not received FDA approval.

What clinical trials is GEM103 in?

GEM103 has one completed Phase 1 clinical trial, identified as NCT04246866. This first-in-human study evaluated the safety and tolerability of GEM103 in 12 participants with geographic atrophy secondary to dry age-related macular degeneration. The trial was conducted in the United States and enrolled adults aged 50 years and older.

Is GEM103 the same as any other drug?

No alternative names for GEM103 have been identified. The drug is known only by its code name GEM103 and is being developed by Disc Medicine, Inc. for the treatment of dry age-related macular degeneration.