STOCKHOLM, March 7, 2024 /PRNewswire/ — Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather’s GABA_A-receptor positive allosteric modulator, GT-002, in healthy volunteers.

The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002. The secondary objective to demonstrate target engagement in human brain was also met. The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

Clinically relevant effects of GT-002 were observed on modulation of EEG frequency band power with a significant increase in alpha band power, compared to Lorazepam at the 2-hour after treatment. This effect spanned various brain regions, including frontal and occipital areas. No significant effect of Lorazepam on EEG alpha band power compared to placebo was observed. The results suggest a distinct effect of GT-002 to modulate alpha band power across specific cortical regions.

EEG alpha band power is recognized as a marker of cognitive activity such as attention and associated with relaxation and less anxiety, an increase in alpha band may be beneficial for a number of different neuropsychiatric conditions. Of particular clinical interest are the reports that negative symptoms in schizophrenia patients are associated with reduced EEG alpha band power.

“We have now proven clinically relevant target engagement in the human brain following oral administration of GT-002 showing that EEG and neuroimaging techniques can indeed open ‘a window into the brain’ and drive the drug development process of our candidate drugs. The next data to be presented will be a refined analysis of the EEG data during task performance and the fMRI neuroimaging data. With these results at hand, we will move forward into clinical trials in patients and identify the right partner for the continued development of GT-002,” says Michael-Robin Witt, CEO of Gabather AB.

 GT-002 Background

GT-002 is a small molecule GABA_A receptor Positive Allosteric Modulator (PAM) eliciting both tonic and phasic inhibitory currents. GT-002 improves learning and memory in preclinical models. It restores ketamine induced cognitive deficits in the discrimination learning task model, and inhibits the behavioural effects induced by phencyclidine in the in-vivo model of schizophrenia. GT-002 has been shown to be anxiolytic and to promote social interaction in rats. GT-002 targets a novel binding site on GABA_A receptors, different from benzodiazepines (BZD), and has not shown any of the side effects known for BZD. Long-term treatment (28 days) with GT-002 has not shown any withdrawal symptoms upon cessation of treatment both in mice and dogs, indicating no drug abuse liability associated with this drug candidate. GT-002 has successfully completed three phase I clinical trials in healthy volunteers. Both single ascending dose (SAD) and multiple ascending dose (MAD) studies have been completed. The results from these studies show that GT-002 is safe and well tolerated and that it has excellent pharmacokinetic properties, allowing for once-a-day oral dosing.

Contact Information

Michael-Robin Witt, CEO

Phone: 073-687 28 39

E-mail: [email protected]

About Gabather

Gabather is a clinical-stage pharmaceutical company aiming to transform the treatment of neuropsychiatric disorders. The Company was founded as a response to the significant unmet need and lack of innovative therapeutics in the mental health treatment landscape. Gabather is dedicated to developing innovative therapeutics for the treatment of a broad range of neuropsychiatric disorders. The goal is to accelerate the development of new groundbreaking medicines to achieve clinically meaningful therapies for the patients.

For more information, please visit: www.gabather.com

Certified Adviser

Corpura Fondkommission AB

Phone: +4672-252 34 51

Email: [email protected] 

www.corpura.se

Forward-looking statement

This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release. Gabather is listed on First North Growth Market and Corpura Fondkommission AB is Certified Advisor.

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