Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tinlarebant (LBS-008), LBS-008
Tinlarebant · 6 trials · 6 indications
Area under the plasma concentration versus time curve from time 0 to the last time point with quantifiable concentration (AUC0-t)
Time of minimal RPB4 levels post-dose (Tmin)
To evaluate safety and tolerability of daily dosing of tinlarebant assessed by incidence and/or severity of ocular and non-ocular adverse events.
To determine optimal dose of tinlarebant administered orally in adolescent patients with Stargardt Disease.
| Arm | Type | Description |
|---|---|---|
| LBS-008, Tinlarebant | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Tinlarebant | EXPERIMENTAL | 5 mg tablet taken orally once a day |
| Cohort 1: 5 mg, fasted | ACTIVE_COMPARATOR | A single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1. |
| Cohort 2: 10 mg, fasted | ACTIVE_COMPARATOR | A single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1. |
| SAD - Cohort 1 | EXPERIMENTAL | 50 mg LBS-008 or placebo |
| SAD - Cohort 2 | EXPERIMENTAL | 100 mg LBS-008 or placebo |
| SAD - Cohort 3 | EXPERIMENTAL | 200 mg LBS-008 or placebo |
| SAD - Cohort 4 | EXPERIMENTAL | 400 mg LBS-008 or placebo |
| SAD - Cohort 5 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 1 | EXPERIMENTAL | 10 mg LBS-008 or placebo |
| MAD - Cohort 2 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 3 | EXPERIMENTAL | 5 mg LBS-008 or placebo |
| MAD - Cohort 4 | EXPERIMENTAL | 12 mg LBS-008 or placebo |
| Name | Type | Description |
|---|---|---|
| Tinlarebant | DRUG | 5 mg tablet taken orally once a day |
| Placebo | DRUG | Placebo tablets for tinlarebant 5 mg prepared similarly. |
| Tinlarebant (LBS-008) | DRUG | A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1. |
| LBS-008 | DRUG | LBS-008 oral capsules |
| Placebos | DRUG | Oral capsules |
Inclusion Criteria: * Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes. * Minimum BCVA is required in the study eye Exclusion Criteria: * The presence of diabetic macular edema or macular disease in either eye. * Diabetic retinopathy more advanced than mild n...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Tinlarebant is an investigational oral small molecule developed by Belite Bio, Inc. (ticker BLTE) for retinal diseases. It is being studied in Stargardt disease, geographic atrophy, and dry age-related macular degeneration. It is not approved and remains in clinical development.
Tinlarebant is being studied as a treatment for Stargardt disease, including STGD1, an inherited retinal condition that causes progressive vision loss. It is investigational and has not been approved for any indication. Clinical testing includes adolescent and adult patients with Stargardt disease.
Tinlarebant targets retinol-binding protein 4, or RBP4. By binding RBP4, the drug is designed to reduce the transport of vitamin A into the eye, which is intended to limit the buildup of toxic vitamin A byproducts in the retina that drive Stargardt disease and geographic atrophy.
Tinlarebant is being developed by Belite Bio, Inc., which trades under the ticker BLTE. The company is advancing the drug across ophthalmology indications including Stargardt disease, geographic atrophy, and dry age-related macular degeneration.
Tinlarebant is in clinical development and is not FDA approved. It has completed Phase 1 studies and is being evaluated in later-stage trials, including a Phase 2/3 study in Stargardt disease and a Phase 3 study in geographic atrophy.
Tinlarebant trials include NCT06388083, a Phase 2/3 study in Stargardt disease, and NCT05949593, a Phase 3 study in geographic atrophy. Completed studies include NCT05667688, a Phase 1 pharmacokinetics study in healthy volunteers, and NCT05266014, a Phase 1 dose-finding study in adolescents with Stargardt disease.
Yes, tinlarebant is also known as LBS-008. Both names refer to the same investigational oral small molecule developed by Belite Bio, Inc. for Stargardt disease, geographic atrophy, and dry age-related macular degeneration.