Gabather Collaborates with Danish Centre for Schizophrenia Research on GT-002 Phase II Trial

Gabather AB, a pharmaceutical firm listed on the Nasdaq First North Growth Market, has entered into a partnership with the Centre for Neuropsychiatric Schizophrenia Research in Glostrup to initiate a phase II clinical trial of GT-002, a drug designed to treat schizophrenia. The trial, funded by the Innovation Fund Denmark (IFD), will evaluate the impact of GT-002 on the EEG patterns and cognitive functions of individuals with schizophrenia, with a budget of approximately 18.6 million Swedish Krona, equivalent to 12 million Danish Krona.

The study, set to run for three years, is a double-blind, randomized trial that will involve 20 schizophrenia patients and 30 healthy individuals. It will be led by Professor Bjørn H. Ebdrup, the head of research at the Centre for Neuropsychiatric Schizophrenia Research (CNSR), a renowned institution with extensive experience in treating various neuropsychiatric disorders.

The collaboration with Gabather is timely, as new links between schizophrenia and the GABA system are being discovered. The CNSR aims to assess the clinical implications of influencing the GABA system in schizophrenia patients. Positive results could pave the way for further studies and ultimately lead to new treatment options for patients.

GT-002 is a GABAA receptor Positive Allosteric Modulator (PAM) that has undergone three clinical trials with healthy volunteers, demonstrating safety and tolerability. The drug has shown to modulate EEG frequency band power, particularly increasing alpha band power, which is associated with cognitive processes like attention and linked to relaxation and reduced anxiety. This modulation could be particularly beneficial for addressing the negative symptoms of schizophrenia, which are connected to decreased EEG alpha band power.

Michael-Robin Witt, CEO of Gabather AB, highlights the significance of this trial for the advancement of GT-002, the company's main pipeline asset. A successful outcome could establish a foundation for developing innovative treatments for schizophrenia and improving the lives of those with neuropsychiatric disorders.

GT-002 has also demonstrated anxiolytic properties and the ability to promote social interaction in rats. It targets a unique binding site on GABAA receptors, distinct from benzodiazepines, without exhibiting their known side effects. After a 28-day treatment period in mice and dogs, no withdrawal symptoms were observed, suggesting no potential for drug abuse. The drug has completed phase I trials with favorable pharmacokinetics, supporting once-daily oral administration. An EEG/fMRI study in healthy volunteers indicated that GT-002 can modulate brain activity across various regions and networks, pointing to its potential in treating a range of neuropsychiatric conditions.

Gabather AB is committed to developing groundbreaking treatments for a wide array of neuropsychiatric disorders, aiming to fulfill the significant need for innovative therapies in mental health care.