Danish Researchers to Test New Drug for the Treatment of Cognitive Impairment Associated with Schizophrenia

A Danish research project in collaboration with the Swedish pharmaceutical company, Gabather AB, will test the efficacy of a new candidate drug (GT-002) for the treatment of schizophrenia. Unlike the classic dopamine-blocking antipsychotic drugs, GT-002 is a GABAA modulator. GT-002 has shown promising results in animal studies and has undergone three clinical trials in healthy volunteers, where it has proved to be safe and well-tolerated. The new trial will test GT-002 for the first time in patients with schizophrenia, whereby promising results will open up possibilities for a new type of treatment for patients with schizophrenia.

Schizophrenia is a severe mental disorder characterised by significant impairments in the way the world is perceived and experienced. Despite considerable advancements in the treatment of schizophrenia, treatments are ineffective in 25% of patients with schizophrenia. Moreover, there is a significant lack of effective treatment avenues for the cognitive impairment associated with schizophrenia (CIAS), which affects a large number of patients. These cognitive deficits include
difficulties with memory, concentration, and planning, and can severely hamper an individual’s ability to pursue education, hold down a job or engage in social interactions.

Antipsychotic medication plays an essential role in the treatment of schizophrenia. These drugs have different mechanisms of action but generally work by suppressing the activity of the neurotransmitter dopamine, the brain's pleasure (or reward) neurotransmitter. However, new research from the Center for Neuropsychiatric Schizophrenia Research (CNSR) at Psychiatric Center Glostrup, Denmark suggests that there are also disturbances in the GABA system in schizophrenia. GABA (Gammaaminobutyric acid) is an important inhibitory neurotransmitter released from nerve cells in most areas of the central nervous system. The Swedish pharmaceutical company Gabather specialises in developing drugs that specifically affect the brain's GABA system. Gabather’s new drug candidate GT-002 has shown promising results in animal studies; and clinical trials with GT-002 in healthy individuals have demonstrated that the drug is entirely safe to administer and has a very mild side effect profile. The results of this project will represent an important step towards better treatment of patients with schizophrenia, providing hope for a substantial improvement in the quality of life for this highly vulnerable group of patients.

Project leader Bjørn H. Ebdrup, head of research at the Center for Neuropsychiatric Schizophrenia Research (CNSR) at Psychiatric Center Glostrup and professor of neurobiologically based treatment of psychosis at the University of Copenhagen, says the following about the project:

- Rarely has the timing of a project been better than in this case: while we in schizophrenia research are uncovering several new connections between schizophrenia and the GABA system, the collaboration with Gabather gives us the opportunity to test the clinical significance of actively influencing the GABA system in patients with schizophrenia. If our studies show positive results, the collaboration will provide optimal conditions to quickly proceed with necessary additional studies, which will ultimately benefit patients.".

With an investment from the Innovation Fund, it will be possible to conduct the first study with GT-002 in patients with schizophrenia in a so-called phase II double-blind randomised study investigating the effect of GT-002 compared to placebo and a benzodiazepine which binds to the GABAA receptors and enhances the effect of GABA on cognition and the brain's early information processing as measured by electroencephalography (EEG). EEG testing uses an electrode cap that is attached to the head and connected to a device that reads activity in the brain.

The study will be conducted by the Center for Neuropsychiatric Schizophrenia Research (CNSR) in collaboration with Gabather. CNSR has many years of experience with brain disorders and cognitive difficulties in schizophrenia. The study has the potential to improve the treatment and functioning of patients with schizophrenia, enabling them to live a better life with the disease as well as being the starting point of a new generation of therapeutics in the treatment of CIAS.

Contact

Bjørn Ebdrup, Professor, Chief (Consultant) Physician and Head of the Center for Neuropsychiatric Schizophrenia Research (CNSR), Psychiatric Center Glostrup. bjoern.ebdrup@regionh.dk 

Facts

The Innovation Fund Denmark's investment: 6 million DKK. 

Total budget: 12 million DKK

Duration: 3 years

Official title: TOTEMS: GT-002, A Promising New Treatment for Cognitive Impairment Associated with Schizophrenia

About the partners

The Center for Neuropsychiatric Schizophrenia Research (CNSR) is a multidisciplinary research unit focusing on psychosis development, the complex mechanisms leading to the development of psychopathology by identifying biological markers of psychological vulnerability, investigating brain changes in the early stages of the disease, and developing new treatment perspectives. CNSR is led by professor Bjørn Ebdrup and is part of Psychiatric Center Glostrup, Capital Region of Denmark Psychiatry.

For further information about CNSR, please visit: www.cnsr.dk

Gabather is a Swedish pharmaceutical company specialising in developing next-generation drugs for neuropsychiatric disorders with a focus on GABAA receptor positive allosteric modulators (PAMs). Gabather’s candidate drug pipeline is based on results from academic research at the Universities of Copenhagen and Lund, as well as the Institute of Biological Psychiatry, Roskilde. Gabather’s drug candidate pipeline holds potential for the treatment of a number of neuropsychiatric illnesses.

For further information about Gabather, please visit: www.gabather.com