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ML-004 · 2 trials · 1 indication
Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.
| Arm | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | EXPERIMENTAL | ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets). |
| ML-004 Placebo | PLACEBO_COMPARATOR | Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets). |
| Name | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | DRUG | Participants will receive ML-004 once daily. |
| ML-004 Placebo | DRUG | Participants will receive matching placebo once daily. |
Inclusion Criteria: * Has completed Study ML-004-002 within the past 90 days * Age 12 years to 46 years at screening * Has a designated care/study partner who can reliably report on symptoms * Has a diagnosis of Autism Spectrum Disorder (ASD) * Has a body mass index (BMI) ≥18 kg/m² * Psychoactive m...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | Xanomeline and trospium chloride, KarX-EC |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 |
ML-004 is an investigational small molecule being developed for Autism Spectrum Disorder (ASD). It is currently in Phase 2 clinical development and is not approved by the FDA. The drug is being studied in adolescents and adults aged 12 years and older.
ML-004 targets the 5-HT1B/1D receptors, which are subtypes of serotonin receptors. By modulating these receptors, the drug aims to address symptoms associated with Autism Spectrum Disorder. This mechanism is being evaluated in clinical trials to assess its safety and efficacy.
ML-004 is being developed by MapLight Therapeutics, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol MPLT. MapLight is conducting clinical trials to evaluate ML-004 for the treatment of Autism Spectrum Disorder.
ML-004 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials have been conducted: one completed and one active but not recruiting, both focusing on Autism Spectrum Disorder in adolescents and adults.
ML-004 has been studied in two Phase 2 trials. NCT05081245, a completed study, enrolled 168 participants. NCT05889273, an active open-label extension study, is not recruiting and has enrolled 120 participants. Both trials involve adolescents and adults with Autism Spectrum Disorder in the US, Australia, and Canada.