Gabather reports initial positive results from the EEG/fMRI target engagement study

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 GABAA 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 GABAA 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.