Gabather reports initial positive results from the EEG/fMRI target engagement study
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Insights
The recent findings from Gabather AB's phase Ib study on GT-002, a GABAA-receptor positive allosteric modulator, are noteworthy in the field of neuropsychiatric drug development. The primary objective of confirming the safety and tolerability profile of GT-002 has been met, which is a critical milestone in the progression of any pharmaceutical candidate. Moreover, the secondary objective of demonstrating target engagement in the human brain, as evidenced by modulation of EEG frequency band power, particularly the alpha band, is significant. Alpha band power is linked to cognitive functions and its increase could imply potential therapeutic benefits for neuropsychiatric conditions like schizophrenia, where negative symptoms have been associated with reduced EEG alpha band power.
GT-002's differentiation from benzodiazepines, targeting a novel binding site on GABAA receptors, could position it as a safer alternative with less risk of dependency. This aspect is particularly important given the current concerns about the abuse potential of benzodiazepines. The absence of withdrawal symptoms in long-term preclinical studies further underscores its safety profile. The pharmacokinetics of GT-002, allowing for once-a-day oral dosing, also enhances its potential for compliance in a clinical setting.
The application of EEG and fMRI neuroimaging techniques in Gabather's study represents an advanced approach to understanding the brain's response to pharmacological interventions. The ability to visualize 'a window into the brain' and observe changes in specific brain regions, such as frontal and occipital areas, adds a layer of precision to the drug development process. This is especially relevant in the neuropsychiatric field, where the correlation between brain activity patterns and behavioral symptoms is complex.
The observed effects of GT-002 on EEG alpha band power could suggest its potential to modulate attention and anxiety levels, which are often disrupted in neuropsychiatric disorders. The upcoming refined analysis of EEG data during task performance and fMRI neuroimaging data will likely provide further insight into the cognitive and neural mechanisms affected by GT-002, which is crucial for tailoring treatment strategies for specific patient populations.
The progression of GT-002 into patient trials is a significant step for Gabather AB, as it transitions from studies in healthy volunteers to those with neuropsychiatric disorders. The success in early-phase trials is not a guarantee of future clinical success, but it does lay a promising foundation. The company's intent to seek a development partner reflects a strategic move to mitigate risks and share the financial burden associated with later-stage trials. It is also indicative of the candidate's perceived viability and market potential.
Future clinical trials will need to address the efficacy of GT-002 in a patient population, as well as any long-term safety concerns that might arise from chronic use. The design of these trials will be critical, especially in determining the optimal dosing strategy and in selecting endpoints that accurately reflect meaningful clinical improvements. The results from these trials will have a significant impact on the drug's regulatory pathway and its potential market positioning.
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.
Contact Information
Michael-Robin Witt, CEO
Phone: 073-687 28 39
E-mail: mrw@gabather.com
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: ca@corpura.se
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.
The following files are available for download:
https://mb.cision.com/Public/11735/3942198/9693ab2d0c4c3557.pdf | PM positive clinical data GT-002 2024-03-07 |
View original content:https://www.prnewswire.com/news-releases/gabather-reports-initial-positive-results-from-the-eegfmri-target-engagement-study-302082660.html
SOURCE Gabather AB
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