Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LB-102 · 6 trials · 2 indications
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
| Arm | Type | Description |
|---|---|---|
| LB-102 | OTHER | An open label study |
| LB-102 (50 mg tablet) | EXPERIMENTAL | • LB-102 50 mg given orally for 6 weeks |
| LB-102 (100 mg tablet) | EXPERIMENTAL | LB-102 100 mg given orally for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo given orally for 6 weeks |
| LB-102, 50 mg QD | EXPERIMENTAL | Oral LB-102: 50 mg (n \~ 105) |
| LB-102, 75 mg QD | EXPERIMENTAL | Oral LB-102: 75 mg (n \~ 105) |
| LB-102, 100 mg | EXPERIMENTAL | Oral LB-102: 100 mg (n \~ 35) |
| Placebo comparator | PLACEBO_COMPARATOR | Drug: Placebo Matched placebo tablets |
| LB-102 50 mg, single dose Cohort 1 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 mg, single dose Cohort 2 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 75 mg, single dose Cohort 3 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 & 50 mg, multiple dose Cohort 4 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for four days in 4 subjects: 2 subjects @ 100 mg and 2 subjects @ 50 mg. |
| Part A Cohort 1 | ACTIVE_COMPARATOR | LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 2 | ACTIVE_COMPARATOR | LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 3 | ACTIVE_COMPARATOR | LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 4 | ACTIVE_COMPARATOR | LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 5 | ACTIVE_COMPARATOR | LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day |
| Part B Cohort 6 | ACTIVE_COMPARATOR | LB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 7 | ACTIVE_COMPARATOR | LB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 8 | ACTIVE_COMPARATOR | LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Name | Type | Description |
|---|---|---|
| LB-102 | DRUG | LB-102 flexible dosing 50 mg - 100 mg |
| LB-102 (50 mg tablet) | DRUG | LB-102 oral tablet given for six weeks |
| LB-102 (100 mg tablet) | DRUG | LB-102 oral tablet given for six weeks |
| Placebo | OTHER | Placebo tablet given orally for six weeks |
Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 70 at screening * CGI-S \</+ 3 at screening * Medically stable * BMI 18 -40 * Taking oral antipsychotic treatment for at least 30 days * Have stable living environment Exclusion Criteria: * Sexually active M/F patients not ...
LB-102 is an investigational small molecule being developed for the treatment of schizophrenia and bipolar I disorder. It is currently in Phase 2 clinical development for both indications. LB-102 is being studied in adult patients with acute schizophrenia and in adult patients with bipolar I disorder major depressive episodes.
LB-102 is being developed by LB Pharmaceuticals Inc, a biopharmaceutical company. The company's stock is traded under the ticker LBRX. LB Pharmaceuticals is conducting clinical trials of LB-102 in the United States.
LB-102 is in Phase 2 clinical development. It has completed Phase 1 trials and a Phase 2 trial in acute schizophrenia, and a Phase 2 trial in bipolar I disorder is currently recruiting participants. LB-102 is investigational and has not been approved by the FDA.
LB-102 has been studied in several clinical trials. Completed trials include a Phase 1 safety and tolerability study (NCT04187560), a Phase 1 PET receptor occupancy study (NCT04588129), and a Phase 2 placebo-controlled trial in acute schizophrenia (NCT06179108). A Phase 2 trial in bipolar I disorder (NCT07494305) is currently recruiting.
Yes, LB-102 (50 mg tablet) refers to the same drug, LB-102, in its oral tablet formulation. The 50 mg tablet is the dosage form being evaluated in clinical trials for schizophrenia and bipolar I disorder.
LB-102 is a small molecule being studied for its effects in psychiatric conditions. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated in randomized, double-blind, placebo-controlled trials to assess its efficacy and safety.