Gabather AB

STOCKHOLM, April 10, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) announces that the Company has signed a Collaborative Agreement with the Centre for Neuropsychiatric Schizophrenia Research at the Psychiatric Centre in Glostrup to conduct a so-called clinical phase II study with GT-002 in patients diagnosed with schizophrenia. The clinical trial has been made possible by a contribution from the Innovation Fund Denmark (IFD) and will test the effect of GT-002 on EEG patterns and cognitive parametres in schizophrenia. The total budget for the study corresponds to approximately 18.6 MSEK amounting to 12 MDKK. The findings of this study hold the promise of unveiling novel avenues for treating patients with schizophrenia. Funded by an Investment Agreement from the Innovation Fund Denmark (IFD), it will now be possible to conduct the first study with GT-002 in patients with schizophrenia. The study is a double-blind randomised so-called phase II study investigating the effect of GT-002 compared to placebo and an active comparator. The 3-year study, aiming at recruiting 20 patients and 30 healthy volunteers will be conducted by the Centre for Neuropsychiatric Schizophrenia Research (CNSR), with Professor Bjørn H. Ebdrup, head of research at the CNSR, as the Principal Investigator. CNSR is a well-recognised psychiatric centre with many years of experience seeing patients with different neuropsychiatric disorders. "Rarely has the timing of a project been better than in this case; while within schizophrenia research we 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" Professor Bjørn H. Ebdrup states. GT-002 has completed 3 clinical trials in healthy volunteers and has been shown to be safe and well tolerated. The most recent target engagement study showed clinically relevant effects of GT-002 on modulation of EEG frequency band power with a significant increase in alpha band power. This effect spanned various brain regions, including frontal and occipital areas. The results suggest a distinct effects of GT-002 to modulate alpha band power across specific cortical regions. EEG alpha band power is recognised as a marker of cognitive activity such as attention and is associated with relaxation and reduced anxiety. Modulation of EEG alpha band power could be beneficial for several neuropsychiatric conditions, especially negative symptoms in schizophrenia that has been shown to be associated with reduced EEG alpha band power. "This clinical trial in patients with schizophrenia represents a major step forward in the development of the main asset in our pipeline, GT-002. A positive study outcome could serve as a cornerstone for the development of innovative therapeutic options for the treatment of schizophrenia and improve the quality of life for individuals suffering from diverse neuropsychiatric disorders, a long term goal for the drug development projects at Gabather AB" says Michael-Robin Witt, CEO of Gabather AB. About GT-002 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 a discrimination learning task model, and inhibits the behavioural effects induced by phencyclidine in an 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 (BZDs), and has not shown any of the side effects known for BZDs. 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 completed 3 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 pharmacokinetics, allowing for once-a-day oral dosing. A recently completed EEG/fMRI target engagement study in healthy volunteers shows that GT-002 modulates brain activity across different brain regions and neuronal networks, indicating a unique profile of GT-002 for the treatment of different neuropsychiatric disorders. 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: Certified Adviser Corpura Fondkommission AB Phone: +4672-252 34 51 Email: [email protected] 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. This information was brought to you by Cision The following files are available for download:

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 GABAA-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 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: [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: Certified Adviser Corpura Fondkommission AB Phone: +4672-252 34 51 Email: [email protected] 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: