The EEG/fMRI study was designed to evaluate the safety, tolerability, pharmacokinetics, target engagement and functional connectivity of brain networks of GT-002. The study included 26 healthy volunteer subjects, of which 17 subjects completed all treatments. Data analysis is currently in progress, and the final study report, including the EEG/fMRI results, will be available once 2CA-Braga has completed the comprehensive analysis of all the collected data. In parallel with the data analysis, preparations for the continued clinical development of GT-002 is ongoing.
"We are pleased to report the completion of the clinical phase of our third Phase 1 study of GT-002, in which we have investigated the effects of GT-002 on functional brain activities," said
About GT-002
GT-002 is a small molecule GABAA receptor positive allosteric modulator (PAM), eliciting both tonic and phasic inhibitory currents. It has high selectivity and affinity for the GABAA receptor, with sub-nanomolar binding affinity to the GABAA receptor. No other targets than the GABAA receptor have so far been identified. The functional roles of phasic inhibition are to prevent overexcitation of neurons and thereby inhibiting development of pathological states of network activity leading to excitotoxicity and neuronal death, which is an essential physiological role of GABA-releasing interneurons and GABAA receptors in the adult CNS. GT-002 has been shown to enhance GABA elicited currents and prolong the decay time. Effects on gamma frequency oscillations has been shown in-vitro, and in pre-clinical animal models. GT-002 has also been shown to improve memory and cognition, promote social interaction, inhibit psychosis and to have anti-depressive effects. In Phase 1 clinical trials in healthy volunteers, GT-002 was shown to have an excellent pharmacokinetic profile, as well as being safe and well tolerated by all subjects. The unique profile of GT-002 warrants further clinical development in indications where dysregulation of the excitatory/inhibitory (E/I) balance could be targeted to prevent disease progression.
Contact Information
Phone: 073-687 28 39
E-mail: mrw@gabather.com
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Email: ca@corpura.se
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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.
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