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Also known as Active Drug
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 \</= 80 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 ...
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LB-102 is an investigational small molecule being developed for the treatment of Bipolar I Disorder and Schizophrenia. It is currently in Phase 2 clinical development for these psychiatric conditions. The drug is being studied in adult patients with these indications.
LB-102 targets the D2, D3, and 5HT7 receptors. These are molecular targets involved in dopamine and serotonin signaling pathways, which are relevant to the treatment of psychiatric disorders such as schizophrenia and bipolar disorder.
LB-102 is being developed by LB Pharmaceuticals Inc, a biopharmaceutical company. The company's stock ticker is LBRX. LB Pharmaceuticals is conducting clinical trials to evaluate the safety and efficacy of LB-102 in patients with schizophrenia and bipolar I disorder.
LB-102 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in clinical trials for the treatment of Bipolar I Disorder and Schizophrenia.
LB-102 is being evaluated in several clinical trials. NCT07494305 is a Phase 2 study in Bipolar I Disorder, NCT07369154 is a Phase 3 open-label safety study in Schizophrenia, and NCT07363577 is a Phase 3 study in acute Schizophrenia. A Phase 2 trial, NCT06179108, has been completed.