SPT-300 for Depression

Enrolling by invitation at 22 trial locations

Overseen By Clinical trial information desk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seaport Therapeutics

Disqualifiers: Noncompliance, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of SPT-300 for individuals with major depressive disorder (MDD), a condition affecting mood and emotional well-being. Participants take SPT-300 capsules once daily for 42 days. The trial is open to those who have completed a previous study with this treatment and do not plan to become pregnant. Participants must also agree to avoid recreational drugs during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in MDD treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that SPT-300 is likely to be safe for humans?

Research has shown that SPT-300, also known as GlyphAllo, has been safe in earlier studies. Data from a past study indicated that SPT-300 was well-received by participants and had a good safety record, with most people not experiencing serious side effects. It also helps increase the body's levels of allopregnanolone, a compound that affects mood, without major safety issues.

While these results are promising, it's important to remember that this treatment is still under study. Ongoing research will continue to assess its safety and tolerability. Prospective participants should consult a healthcare professional to understand the implications of joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SPT-300 for depression because it may offer a novel approach to treatment. Most current treatments, like SSRIs and SNRIs, work by altering neurotransmitter levels, which can take weeks to show effects. SPT-300, however, might work faster by targeting a different pathway in the brain, potentially providing relief in just days. This could be a game-changer for those who need quicker results to manage their symptoms effectively.

What evidence suggests that SPT-300 might be an effective treatment for depression?

Research shows that SPT-300, also known as GlyphAllo, may help treat major depressive disorder (MDD). The main ingredient, allopregnanolone, has proven effective in other studies as a fast-acting antidepressant and anxiety reducer. Studies have found that SPT-300 reaches blood levels up to nine times higher than other oral forms of the same compound, potentially enhancing its effectiveness. These findings suggest that SPT-300 could be an effective treatment for people with depression, including those experiencing anxiety. ^{1 5 6 7 8}

Who Is on the Research Team?

David Walling, Ph.D.

Principal Investigator

Collaborative Neuroscience Research - Garden Grove

Are You a Good Fit for This Trial?

This trial is for adults with major depressive disorder (MDD), which may include symptoms of anxiety. Participants must have completed a prior study with SPT-300 and shown that they can tolerate the medication without significant issues.

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])

Participant is willing and able to refrain from the use of drugs of abuse

I am not planning to get pregnant or breastfeed, and will use effective birth control during and for 30 days after the study.

Exclusion Criteria

Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study

Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study)

I am not pregnant, or I am surgically sterile or post-menopausal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPT-300 capsules once daily for 42 days

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Open-label extension

Participants continue to receive SPT-300 to evaluate long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• SPT-300

Trial Overview

The trial is testing the long-term safety and tolerability of a drug called SPT-300 (GlyphAllo) when used alone in treating adults with major depressive disorder, including those who also experience anxious distress.

How Is the Trial Designed?

Group I: SPT-300 Experimental Treatment 1 Intervention

Participants will receive SPT-300 capsules once daily for 42 days

Who Is Running the Clinical Trial?

Seaport Therapeutics

Lead Sponsor

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD

Premier Research

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07065240

A Study to Evaluate the Efficacy and Safety of SPT-300 ...

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 ( ...

2.

news.puretechhealth.com

news.puretechhealth.com/news-releases/news-release-details/puretech-founded-entity-seaport-therapeutics-presents-additional

SPT-300 at ACNP Annual Meeting 2024 - PureTech News

Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects. New data ...

3.

seaporttx.com

seaporttx.com/press-release/seaport-therapeutics-announces-first-patient-dosed-in-phase-2b-buoy-1-study-of-glyphallotm-spt-300-in-major-depressive-disorder-mdd-with-or-without-anxious-distress/

BUOY-1 builds on successful Phase ...

The first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo TM (SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07161700

Study Details | NCT07161700 | An Open-Label Extension ...

This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD) ...

5.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/seaport-therapeutics-sees-success-with-allopregnanolone-prodrug/

Seaport Therapeutics sees success with allopregnanolone ...

The study found that SPT-300 had therapeutically relevant blood levels up to nine times greater than that found in published data on orally ...

6.

investors.puretechhealth.com

investors.puretechhealth.com/news-releases/news-release-details/puretech-founded-entity-seaport-therapeutics-announces-first

News Release Details

PureTech Founded Entity Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo™ (SPT-300) in Major Depressive ...

7.

seaporttx.com

seaporttx.com/press-release/seaport-therapeutics-presents-data-from-multiple-spt-300-trials-at-society-of-biological-psychiatry-sobp-annual-meeting/

Seaport Therapeutics Presents Data from Multiple SPT-300 ...

SPT-300 demonstrated nine times greater allopregnanolone exposure in humans dosed orally than published data for oral allopregnanolone.

8.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/spt-300-a-promising-oral-neurosteroid-for-mood-and-anxiety-disorders/

SPT-300: A Promising Oral Neurosteroid for Mood and ...

Data from a Phase 1 trial indicates that SPT-300 is well-tolerated and has a favorable safety profile. ... Elironrasib Safety, Efficacy Data in ...