Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tinlarebant · 5 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. |
| 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. |
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 |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Tinlarebant is an investigational small molecule being developed for Stargardt Disease 1 (STGD1), a form of juvenile macular degeneration, and for Geographic Atrophy, a late-stage form of dry age-related macular degeneration. It is also being studied in healthy volunteers for pharmacokinetic purposes. Tinlarebant is not yet approved and remains in clinical development.
Tinlarebant is a small molecule designed to target the visual cycle. It works by reducing the accumulation of toxic byproducts in the retina that contribute to retinal degeneration in Stargardt Disease and Geographic Atrophy. This mechanism aims to slow disease progression by limiting the formation of these harmful compounds.
Tinlarebant is being developed by Belite Bio, Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol BLTE. The company is conducting clinical trials for Tinlarebant in Stargardt Disease and Geographic Atrophy.
Tinlarebant is currently in Phase 3 clinical development for both Stargardt Disease 1 and Geographic Atrophy. It has received several FDA designations, including Breakthrough Therapy, Fast Track, Orphan Drug, Rare Pediatric Disease, and Priority Review, reflecting its investigational status.
Tinlarebant has been studied in multiple trials. NCT05244304 is a completed Phase 3 placebo-controlled study in adolescent Stargardt Disease. NCT05949593 is an active Phase 3 trial in Geographic Atrophy. NCT05266014 is a completed Phase 1 dose-finding study in Stargardt Disease, and NCT05667688 is a completed Phase 1 study in healthy volunteers.
Yes, Tinlarebant is also known as LBS-008. In clinical trials, the drug has been referred to by both names, with LBS-008 appearing in study titles for pharmacokinetic and pharmacodynamic research. Both names refer to the same investigational compound developed by Belite Bio.