Tinlarebant for Age-Related Macular Degeneration

(PHOENIX Trial)

Not currently recruiting at 51 trial locations

Overseen By Belitebio Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Belite Bio, Inc

Disqualifiers: Diabetic macular edema, Retinopathy, Glaucoma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tinlarebant for individuals with age-related macular degeneration (AMD), a condition that affects vision. The researchers aim to determine if tinlarebant can improve vision in those with geographic atrophy (GA), a specific type of AMD. Participants will receive either tinlarebant or a placebo (a substance without active medicine) to compare results. Ideal candidates for this trial are those diagnosed with GA and without other eye diseases like diabetic macular edema. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that tinlarebant is likely to be safe for humans?

Research has shown that tinlarebant has been tested for safety in conditions like Stargardt disease. In those studies, researchers closely monitored participants for side effects. The results indicated that the treatment was generally well-tolerated, with most side effects being mild.

In ongoing trials, such as the DRAGON trial, the focus remains on tinlarebant's safety. These trials suggest that while some side effects may occur, they are not severe for most people. The treatment is now in a later stage of research, having already passed earlier safety checks. This supports the idea that tinlarebant is safe for humans, but ongoing studies will provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Researchers are excited about Tinlarebant because it offers a fresh approach to tackling age-related macular degeneration (AMD). Unlike standard treatments, which often involve injections into the eye to slow disease progression, Tinlarebant is an oral medication, making it potentially less invasive and more convenient for patients. It works by inhibiting the production of a toxic vitamin A derivative that contributes to AMD, aiming to protect retinal cells and preserve vision. This novel mechanism of action could offer a new hope for those with AMD, potentially reducing the need for frequent eye injections.

What evidence suggests that tinlarebant might be an effective treatment for age-related macular degeneration?

Research has shown that tinlarebant, which participants in this trial may receive, might help treat age-related macular degeneration by reducing harmful substances in the eye called bisretinoids. These substances can accumulate and cause damage. A previous study found that tinlarebant might slow the growth of damaged areas in the eye. This treatment is still under investigation in this trial, but early results suggest it could help protect vision. If successful, tinlarebant could become an important treatment for people with this eye condition. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tinlarebant

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

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Belite Bio Announces Completion of DRAGON, a 2-Year ...

Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05949593

Study Details | NCT05949593 | Phase 3, Randomized, ...

These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior ...

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clinicaltrialsarena.com

clinicaltrialsarena.com/news/belite-bio-stargardt-disease/

Belite Bio wraps up Phase III trial of Stargardt disease ...

“With no approved therapies available today, Tinlarebant has the potential to be the first treatment for this devastating inherited macular ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05244304

Study Details | NCT05244304 | Phase 3, Randomized, ...

Subjects will be assigned to study drug (tinlarebant 5 mg/placebo) with treatment period of upto 24 months with 28 days of follow-up. Official Title. Phase 3, ...

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investors.belitebio.com

investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-completion-enrollment-pivotal-global-phase

Belite Bio Announces Completion of Enrollment in the Pivotal ...

A global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate.

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clinicaltrialsarena.com

clinicaltrialsarena.com/news/belite-bio-tinlarebant/

Enrolment concludes in Belite Bio's trial of Tinlarebant for GA

Belite Bio has completed enrolment in the 24-month PHOENIX Phase III trial assessing the tolerability and safety of oral Tinlarebant.

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ophthalmologytimes.com/view/belite-bio-concludes-phase-3-dragon-study-for-stargardt-disease

Belite Bio concludes phase 3 DRAGON study for Stargardt ...

The phase 3 DRAGON study assessed tinlarebant's efficacy, safety, and tolerability in treating Stargardt disease type 1. Tinlarebant reduces ...

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modernretina.com

modernretina.com/view/belite-bio-completes-phase-3-clinical-trial-plans-for-lbs-008

Belite Bio completes phase 3 clinical trial plans for LBS-008

According to the company, LBS-008 is an orally administered tablet intended as an early intervention to slow disease progression in patients ...