Gabather Initiates Phase II TOTEMS Trial for GT-002 in Schizophrenia Spectrum Disorders
Key Insights
Gabather (search) has launched the TOTEMS phase II clinical trial evaluating drug candidate GT-002 in patients with schizophrenia spectrum disorders (search) at Copenhagen University Hospital.
The study is designed as a double-blind, randomized trial including both schizophrenia patients and healthy controls with continuous data readout capabilities.
CEO Michael-Robin Witt has expressed hopes of publishing an interim report this autumn, marking a significant milestone for the company's psychiatric drug development program.
Gabather (search) has announced the activation of its TOTEMS phase II clinical trial, marking a significant milestone in the development of GT-002 for patients with schizophrenia spectrum disorders (search). The study is being conducted at the Center for Neuropsychiatric Schizophrenia Research (search) (CNSR) at Copenhagen University Hospital, with patient enrollment now imminent.
Trial Design and Implementation
The TOTEMS study is structured as a double-blind, randomized clinical trial that includes both schizophrenia patients and healthy controls. The trial design incorporates continuous data readout capabilities, allowing for ongoing assessment of treatment effects throughout the study period. This approach may enable earlier identification of efficacy signals compared to traditional endpoint-driven studies.
CEO Michael-Robin Witt has indicated that the company hopes to publish an interim report this autumn, providing stakeholders with preliminary insights into GT-002's therapeutic potential. The activation of this long-awaited trial represents a crucial step forward for Gabather (search)'s psychiatric drug development program.
Broader Development Pipeline
Beyond the TOTEMS trial, Gabather (search) has expanded its intellectual property portfolio by filing a patent for a new non-sedating sleep treatment in April. This development suggests the company is diversifying its approach to neuropsychiatric disorders beyond schizophrenia spectrum conditions.
The company has also entered into partnerships specifically aimed at opening doors to licensing discussions, indicating a strategic focus on potential commercialization pathways for its drug candidates. These partnerships could provide additional validation and potential revenue streams as the clinical program advances.
Financial Position and Outlook
Gabather (search)'s first report of 2026 showed an EBIT of KSEK -1,052, which came in close to analyst estimates of KSEK -1,136. The company continues to maintain strict cost control measures while advancing its clinical development programs. Analysts have maintained their fair value assessment of SEK 0.06 per share, with no changes made to financial models following the trial activation announcement.