An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)

Seaport Therapeutics

Status and phase

Invitation-only

Phase 2

Conditions

Major Depressive Disorder With Anxious Distress

Major Depressive Disorder (MDD)

Treatments

Drug: SPT-300

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07161700

2025-522347-18-00 (EU Trial (CTIS) Number)

SPT-300-2024-204

Details and patient eligibility

About

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), with or without anxious distress.

Enrollment

360 estimated patients

Sex

All

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

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 currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
Participant is willing and able to refrain from the use of drugs of abuse.

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).
Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.