Tinlarebant for Age-Related Macular Degeneration

(PHOENIX Trial)

Recruiting at 47 trial locations

Overseen By Belitebio Clinical Operations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Belite Bio, Inc

Disqualifiers: Diabetic macular edema, Retinopathy, Glaucoma, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new pill called tinlarebant in people with Geographic Atrophy, an eye condition that causes vision loss. The goal is to see if the pill can help slow down or stop the progression of the disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug Tinlarebant unique for treating age-related macular degeneration?

Tinlarebant is unique because it is being investigated as a potential treatment for age-related macular degeneration, a condition for which there are currently no cures. Unlike other treatments that focus on managing symptoms, Tinlarebant may target the underlying disease mechanisms, offering a novel approach to potentially stabilize or improve visual acuity. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with confirmed diagnosis of Geographic Atrophy (GA), a form of age-related macular degeneration, who have a certain level of vision remaining. It's not open to those with diabetic eye diseases, advanced diabetic retinopathy, other retinal vascular diseases, or uncontrolled glaucoma in the study eye.

Inclusion Criteria

Minimum BCVA is required in the study eye

I have been diagnosed with GA and have atrophic lesions in one or both eyes.

Exclusion Criteria

I have swelling or disease in the central part of my retina due to diabetes.

My eye condition is more severe than mild diabetic retinopathy.

I have uncontrolled glaucoma in one of my eyes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tinlarebant or placebo orally once daily

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo (Other)
• Tinlarebant (Other)

Trial Overview The trial is testing Tinlarebant against a placebo to see if it's safe and effective for treating GA. Participants are randomly assigned to receive either Tinlarebant or a placebo without knowing which one they're getting.

Participant Groups

Group I: LBS-008, Tinlarebant Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Belite Bio, Inc

Lead Sponsor

Trials

7

Recruited

730+

Findings from Research

In treatment-naive patients with neovascular age-related macular degeneration (nAMD), lower baseline best-corrected visual acuity (BCVA) and higher central retinal thickness (CRT) were predictors of greater visual gains and reductions in CRT after treatment with ranibizumab over 12 months.

Patients who showed a significant improvement in BCVA (≥5 letters) after three initial injections had a high follow-up rate (75.6%) and maintained their visual gains, while those with less improvement still had stable vision, indicating that early treatment response can guide ongoing management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics and treatment response predictive of nAMD outcomes with ranibizumab therapy in treatment-naive patients: the RACER subgroup analysis. Tsai, CY., Wu, CL., Cheng, CK., et al.[2023]

In a 48-week study involving 477 patients with neovascular age-related macular degeneration, the biosimilar FYB201 demonstrated clinical equivalence to the reference drug ranibizumab, with similar improvements in best-corrected visual acuity (BCVA) after 8 weeks.

Both FYB201 and ranibizumab had comparable safety profiles, with adverse events being similar between the two treatment groups, confirming that FYB201 is a safe and effective alternative to the reference drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Holz, FG., Oleksy, P., Ricci, F., et al.[2022]

Several promising therapies for age-related macular degeneration (ARMD) are being explored, including stem cells and neurotrophic factors, which may help stabilize or improve vision, although there is currently no cure.

Current clinical trials are investigating a variety of treatments, such as complement inhibitors and anti-amyloid antibodies, while some therapies like eculizumab and vitamin E have not shown effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on current and future novel therapies for dry age-related macular degeneration. Leung, E., Landa, G.[2013]

Wet age-related macular degeneration (AMD) is recognized as a complex disease involving not just blood vessel growth but also inflammation, prompting researchers to explore new treatments that target multiple aspects of its pathology.

Several new agents, including VEGF blockers and inflammation inhibitors, are currently in human trials or have been approved, indicating a shift towards more comprehensive treatment strategies for wet AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. Ni, Z., Hui, P.[2009]

In a study of 217 patients with neovascular age-related macular degeneration (nAMD) receiving ranibizumab, longer treatment-free intervals (≥2 to ≥6 months) were associated with a decreased likelihood of needing retreatment soon after, indicating potential benefits of extended intervals.

Despite the trend showing that longer treatment-free intervals may lead to longer future disease-free periods, the unpredictability of nAMD disease activity means that regular monitoring is essential for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Prior Response to Anti-Vascular Endothelial Growth Factor for Age-Related Macular Degeneration: A HARBOR Subanalysis. Khurana, RN., Chang, LK., Hill, LF., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics and treatment response predictive of nAMD outcomes with ranibizumab therapy in treatment-naive patients: the RACER subgroup analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Update on current and future novel therapies for dry age-related macular degeneration. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

The Value of Prior Response to Anti-Vascular Endothelial Growth Factor for Age-Related Macular Degeneration: A HARBOR Subanalysis. [2021]