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SPT-300 · 2 trials · 2 indications
Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.
HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.
| Arm | Type | Description |
|---|---|---|
| SPT-300 | EXPERIMENTAL | Participants will receive SPT-300 capsules once daily for 42 days |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo once daily for 42 days |
| Name | Type | Description |
|---|---|---|
| SPT-300 | DRUG | A prodrug of allopregnanolone, a small molecule drug |
| Placebo | DRUG | Placebo for SPT-300 |
Inclusion Criteria: * Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]). * Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currentl...
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SPT-300 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD), including MDD with anxious distress. It is currently in Phase 2 clinical development and has not been approved by the FDA.
SPT-300 targets allopregnanolone, a hormone that modulates brain activity. By acting on this target, SPT-300 is being studied for its potential to address symptoms of Major Depressive Disorder, including those with anxious distress.
SPT-300 is being developed by Seaport Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with Major Depressive Disorder.
SPT-300 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials for Major Depressive Disorder.
SPT-300 is being evaluated in two Phase 2 trials: NCT07065240, a placebo-controlled study in participants with Major Depressive Disorder with or without anxious distress, and NCT07161700, an open-label extension study assessing long-term safety and tolerability.
Yes, SPT-300 is also known as GlyphAllo. Both names refer to the same investigational drug being developed by Seaport Therapeutics for the treatment of Major Depressive Disorder.