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ML-007C-MA · 4 trials · 2 indications
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
| Arm | Type | Description |
|---|---|---|
| ML-007C-MA | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ML-007C-MA QD | EXPERIMENTAL | - |
| ML-007C-MA BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ML-007C-MA | DRUG | ML-007C-MA dosed as 210/3 mg BID |
| Placebo | DRUG | Placebo Tablets |
| ML-007C-MA BID | DRUG | ML-007C-MA dosed as 210/3 mg BID |
| ML-007C-MA QD | DRUG | ML-007C-MA dosed as 330/6 mg QD |
Key Inclusion Criteria: 1. Must be able and willing to provide informed consent for all required study procedures. 2. Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5...
ML-007C-MA is an investigational small molecule being developed for psychosis associated with Alzheimer's disease and for schizophrenia. It is currently in Phase 2 clinical development and has not been approved by the FDA.
ML-007C-MA targets M1 and M4 muscarinic receptors. These receptors are part of the cholinergic system and are being studied for their role in treating psychiatric conditions such as schizophrenia and Alzheimer's disease psychosis.
ML-007C-MA is being developed by MapLight Therapeutics, Inc., a biopharmaceutical company. The company's stock ticker is MPLT.
ML-007C-MA is in Phase 2 clinical development. It has received Fast Track designation from the FDA. The drug is investigational and has not been approved for any use.
ML-007C-MA is being studied in several Phase 2 trials. NCT06887192 is a placebo-controlled study in Alzheimer's disease psychosis. NCT07038876 is a completed study in schizophrenia. NCT07459647 is an open-label long-term study in schizophrenia, and NCT07459660 is an open-label study in Alzheimer's disease psychosis.
ML-007C-MA is a distinct investigational drug targeting M1 and M4 muscarinic receptors. No alternative names for ML-007C-MA have been disclosed. It is being developed specifically for schizophrenia and Alzheimer's disease psychosis.