Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tinlarebant
LBS-008 · 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...
LBS-008 is an investigational small molecule drug developed by Belite Bio, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications for which LBS-008 is being developed have not been publicly disclosed.
LBS-008 is being developed by Belite Bio, Inc., a biopharmaceutical company that trades under the ticker symbol BLTE. Belite Bio is responsible for the clinical development of LBS-008.
LBS-008 has completed a Phase 1 clinical trial. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial, NCT03735810, evaluated the safety and tolerability of LBS-008 in healthy adult subjects after single and multiple doses.
LBS-008 has been evaluated in one completed Phase 1 clinical trial, NCT03735810, titled "Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses." The trial enrolled 71 healthy volunteers in Australia and was randomized, double-blind, and controlled.
No, LBS-008 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. Approval would require successful completion of further clinical testing and regulatory review.