AXT107 for Age-Related Macular Degeneration

(DISCOVER Trial)

Not currently recruiting at 4 trial locations

Overseen By Mary French

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AsclepiX Therapeutics, Inc.

Must be taking: Anti-VEGF

Must not be taking: Brolucizumab, Aflibercept, Ranibizumab, Bevacizumab

Disqualifiers: Non-responders, Retinal detachment, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called AXT107 for individuals with age-related macular degeneration (AMD), a condition affecting vision. Researchers aim to assess the safety of different AXT107 doses and their duration of effectiveness when injected into the eye. The trial will evaluate low, mid, and high doses to determine the optimal balance of safety and effectiveness. Suitable candidates include those partially responding to current AMD treatments but still experiencing fluid or changes in their retina (the back part of the eye that aids vision). Participants will be monitored for nine months following a single injection. As a Phase 1 trial, this research seeks to understand how AXT107 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used certain eye medications like Aflibercept, Ranibizumab, or Bevacizumab close to the start of the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AXT107 could be a promising treatment for age-related macular degeneration (AMD). In earlier studies, participants generally tolerated AXT107 well. Some experienced mild side effects, but these were usually manageable.

AXT107 targets certain proteins in the eye to reduce the growth of abnormal blood vessels, a major issue in AMD. Researchers have tested different doses to find the safest and most effective amount. Ongoing research aims to determine the highest dose that people can handle without significant side effects.

For those considering joining this clinical trial, it's important to know that AXT107 has been tested in humans before, and the safety results have been encouraging. Researchers will continue to monitor its safety to ensure it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AXT107 for age-related macular degeneration because it offers a potentially groundbreaking approach to treatment. Unlike current standard options like anti-VEGF injections, which primarily inhibit blood vessel growth, AXT107 targets both vascular leakage and inflammation, potentially providing a more comprehensive treatment. This novel mechanism could lead to better long-term outcomes and fewer injections, reducing the treatment burden on patients. Additionally, AXT107 is being tested in multiple doses (low, mid, and high), which may help fine-tune its effectiveness and safety profile, offering more personalized treatment options.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research shows that AXT107, a peptide derived from collagen, can block VEGF signals. VEGF is a protein that causes abnormal blood vessels to grow in the eye, contributing to age-related macular degeneration (AMD). AXT107 attaches to certain proteins called integrins, potentially reducing this unwanted growth. Previous studies have demonstrated that AXT107 works well in various experimental models of AMD. Although research in humans is ongoing, these findings suggest AXT107 could effectively treat neovascular age-related macular degeneration (nAMD). This trial will evaluate different doses of AXT107—low, mid, and high—to determine its effectiveness and safety in treating nAMD. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people over 50 with a type of vision loss called nAMD. They must have certain types of eye fluid or changes seen on an eye scan, and their vision should be within a specific range. Participants also need to have had some response to previous treatments that target VEGF, a protein related to blood vessel growth.

Inclusion Criteria

I have AMD with specific vision loss and confirmed CNV affecting my central vision.

Your non-study eye has vision of 20/200 or better on a vision chart.

I am 50 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of AXT107 suprachoroidally

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and bioactivity of AXT107 through regular visits

9 months

Regular monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• AXT107 High Dose
• AXT107 Low Dose
• AXT107 Mid Dose

Trial Overview The study tests three doses of AXT107 given as an injection into the eye area in patients with nAMD. It aims to find out how safe the drug is at its highest dose that can be tolerated and how well it works over nine months after just one injection.

How Is the Trial Designed?

Group I: Mid Dose Experimental Treatment 1 Intervention

AXT107 0.250 mg/eye

Group II: Low Dose Experimental Treatment 1 Intervention

AXT107 0.125 mg/eye

Group III: High Dose Experimental Treatment 1 Intervention

AXT107 0.500 mg/eye

Who Is Running the Clinical Trial?

AsclepiX Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05859776

NCT05859776 | Safety and Bioactivity of AXT107 in ... Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947312/

Anti-angiogenic collagen IV-derived peptide target ... AXT107, a collagen-derived peptide that binds integrins α v β 3 and α 5 β 1 with high affinity, suppresses vascular endothelial growth factor (VEGF) signaling.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04746963

Safety and Bioactivity of AXT107 in Subjects With ... Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (SHASTA). ClinicalTrials.gov ID NCT04746963. Sponsor AsclepiX ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5308917/

Tyrosine kinase blocking collagen IV–derived peptide ... AXT107 has robust efficacy in seven experimental paradigms in ... Retinal angiomatous proliferation in age-related macular degeneration.

5. synapse.patsnap.com synapse.patsnap.com/article/asclepix-therapeutics-completes-enrollment-in-namd-discover-trial

AsclepiX Therapeutics Completes Enrollment in nAMD ... The trial involves three dose levels of AXT107: 125 µg, 250 µg, and 500 µg, with three, three, and nine patients in each group, respectively.

6. ctv.veeva.com ctv.veeva.com/study/safety-and-bioactivity-of-axt107-in-subjects-with-neovascular-age-related-macular-degeneration-namd

Safety and Bioactivity of AXT107 in Subjects With Neovascular ... The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD.

7. nature.com nature.com/articles/s41433-025-04042-3

Novel targets beyond vascular endothelial growth factor-A ... Safety and bioactivity of AXT107 in subjects with neovascular age-related macular degeneration (SHASTA). https://clinicaltrials.gov/study ...