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  • Michael-Robin Witt

    CEO


    http://www.gabather.com
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    Gabather Joins Forces with the Centre for Neuropsychiatric Schizophrenia Research in Denmark to Conduct a Clinical Phase II Study with GT-002

    STOCKHOLM, April 10, 2024 -- 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

    Gabather files two new patent applications to secure novel findings on the effects of GT-002 for the treatment of psychiatric disorders

    STOCKHOLM, March 18, 2024 -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports that two new US provisional patent applications based on novel findings from the EEG/fMRI target engagement study with GT-002, a selective positive allosteric GABAA-receptor modulator. The inventions relate to the medical use of GT-002 in psychiatric disorders.The claims based on inventions from the results from our EEG/fMRI target engagement study are both novel and unexpected and will strengthen Gabather’s intellectual property right (IPR) position in the field of GABA\A\ receptor modulators,

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

    STOCKHOLM, March 7, 2024 -- 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

    Gabather AB receives initial EEG data analysis from the GT-002 target engagement study

    Gabather AB ( www.gabather.com)  has received the  electroencephalography (EEG) analysis of the 17 human healthy volunteers involved in the target engagement study with the lead clinical  candidate GT-002 as part of the collaboration with MINDIG .  The quantitative analysis of the recordings showed statistically significant increase induced by GT-002 on the EEG alpha frequency band power. MINDIG will continue the EEG data analysis and expects to deliver new analysis of the data early next year. “ The EEG data analysis shows that our drug candidate GT-002 ,

    Gabather AB initiates discussions with specialist doctors and researchers at Karolinska Institutet for the design of a study in individuals at risk of developing frontotemporal dementia (FTD)

    Gabather approaching a significant milestone in the clinical development of GT-002. The Company has completed 3 clinical trials so far, each showing that GT-002 is safe and well tolerated in man. The next step in the development of GT-002 is clinical studies in patients with diagnoses where effective treatments are lacking.Discussions with specialist doctors and researchers at the Karolinska Institutet have been initiated for the design of a study in individuals with genetic predispositions to develop FTD. Currently, there are no available specific treatments for FTD, and there is still no

    Gabather AB broadens the scope of EEG data analysis generated during the target engagement study by partnering with MINDIG

    Gabather AB has partnered with MINDIG , a French company with an interdisciplinary team of data scientists, neurologists, and software engineers collaboratively pushing the boundaries of Electroencephalographic (EEG) analysis and neuroscience. The team at MINDIG will conduct a comprehensive and in-depth analysis of the extensive EEG data generated during the EEG/fMRI target engagement study with our lead candidate, GT-002, involving human healthy volunteers. Leveraging MINDIG's top-tier expertise and extensive experience in human brain analysis, this

    Gabather Announces Completion of Phase I EEG/fMRI Target Engagement Study of GT-002 in Healthy Volunteers

    STOCKHOLM, Oct. 12, 2023 -- Gabather (Nasdaq First North Growth Market: GABA), a clinical-stage pharmaceutical company aiming to transform the treatment of neuropsychiatric disorders, announced today the completion of the clinical phase of the EEG/fMRI target engagement study of GT-002 in healthy volunteers. All subjects have received the treatments, and the results show that GT-002 was well-tolerated with a favourable safety profile. The safety data confirms previous results from the two Phase 1 studies, the single ascending dose (SAD) study, and the multiple ascending dose (MAD) study with

    Gabather, Receives Notice of Approval from the Japanese Patent Office (JPO) for its National Phase Application No. 2020-554957

    Gabather AB (Nasdaq First North Growth Market: GABA), a clinical stage pharmaceutical company developing novel therapeutics for neuropsychiatric disorders, is pleased to announce that it has received approval from the JPO for the national phase patent application No. 2020-554957.The invention relates to the synthesis and production of triazoloquinazolinones and is based on the PCT International Application No. PCT/IB2018/001573. The invention expands our position in the field of GABA\A\ receptor modulators and medical use. This patent together with our patent portfolio covers key products

    Gabather AB, receives Notice of Allowance from the U.S. Patent Office for its U.S. patent application publication No. US 2021/0087193 A1

    Gabather AB (Nasdaq First North Growth Market: GABA), a clinical stage pharmaceutical company developing the next generation of therapeutics for neuropsychiatric disorders, is pleased to announce that it has received a Notice of Allowance from the U.S. Patent Office for its U.S. patent application publication No. US 2021/0087193 A1 entitled: Triazoloquinazolinone synthesis.The invention further increases and strengthens Gabather´s position in the field of GABA\A\ receptor modulators and methods of use. Gabather has a portfolio of patents and patent applications covering key products and

    BioStock: Gabather’s lead candidate moves forward in the clinic

    Swedish biotech Gabather has received the approval from the Portuguese authorities to go ahead with a target engagement study to complete the phase I evaluation of GT-002, the company’s candidate targeting mood disorders. As patient recruitment for the study proceeds, BioStock got in touch with CEO Michael-Robin Witt to learn more about the timeline for the study.Read the interview with Michael-Robin Witt at biostock.se: https://www.biostock.se/en/2022/06/gabathers-lead-candidate-moves-forward-in-the-clinic/ This is a press release from BioStock - Connecting Innovation & Capital.

    Gabather receives approval to start the EEG/fMRI target engagement study with the drug candidate GT-002

    Gabather AB (Nasdaq First North Growth Market: GABA) announces today that the company has received approval from the Portuguese regulatory authority, INFARMED, to start the target-engagement study in healthy volunteers with the drug candidate GT-002. Screening and recruitment of individuals will start shortly.GT-002 is our most advanced selective GABA\A\ receptor modulator with a unique mechanism of action that opens for the development of new and effective drugs against several neuropsychiatric diagnoses. In the double-blind, placebo-controlled phase 1 study, healthy subjects will

    Gabather AB invited by the Alzheimer's Drug Discovery Foundation, USA to submit a grant application to expand the studies with GT-002 in preclinical models of Alzheimer's disease

    Gabather has been invited by the Alzheimer´s Drug Discovery Foundation (ADDF), USA to submit a research grant application to further investigate the effects of GT-002 in genetic models of Alzheimer´s disease. The project application is based on the preliminary data with GT-002 on restoring slow wave oscillations in an Alzheimer’s disease model generated during the collaboration between Gabather and Harvard Medical School (HMS). The project includes the teams from Professor Ksenia Kastanenka (HMS) and Professor Simon Schultz, Imperial Collage London, as well as Gabather as project

    BioStock: Gabather poised to complete phase I with GT-002

    As described in their Q2 report, despite the pandemic, Swedish biotech Gabather have taken key steps in the clinical development of its lead candidate GT-002 this year. Since the reporting period, the company has announced submitting an application for initiating a target engagement study with GT-002 in Portugal. If approved, this study will be a gateway to phase II and beyond. BioStock takes a look back at Gabather’s advancements so far this year and discusses the importance of this target engagement study with CEO Michael-Robin Witt.Read the full interview with Michael-Robin Witt at

    BioStock: Covid unmasks need for better mental health medication

    As researchers continue working around the clock to put together the puzzle pieces needed for better understanding Covid-19 pathology, the disease has further exposed a serious lack of treatments for mental health conditions. In Sweden, biotech Gabather is developing new treatments for CNS diseases, including psychiatric disorders that appear in many Covid-19 patients. BioStock got in touch with Gabather’s CEO Dr Michael-Robin Witt, to learn more about how the company’s lead candidate GT-002 could help reduce the Covid-related mental health burden.Read the full interview with Michael-Robin

    BioStock Studio: Gabather gives clinical trial update

    Gabather’s top candidate GT-002 for treating psychiatric or mood disorders like depression, anxiety, and schizophrenia is currently in the early stages of clinical development. The company is planning a key target engagement study in healthy volunteers aimed at showing how GT-002 modulates brain activity at both the functional and regional levels of the brain. The company's CEO Michael-Robin Witt joined BioStock via link to tell us more about GT-002 and give us an update on the ongoing clinical trial.Watch the interview with Gabather's CEO Michael-Robin Witt at biostock.se:  https://www.

    Gabather enters into a research collaboration with leading US scientists to investigate GT-002 in a unique preclinical model of Alzheimer’s Disease

    Gabather AB (Nasdaq First North Growth Market: GABA) today announces the establishment of a research collaboration with Massachusetts General Hospital to investigate the effect of its drug candidate GT-002 in a preclinical model of Alzheimer’s disease. The first stages of the clinical development (single and multiple ascending doses) with GT-002 has recently been successfully completed, paving the way for the development of the drug candidate in a broad range of mental disorders.Gabather has signed an agreement with Massachusetts General Hospital, where Dr Kastanenka, Assistant Professor of

    BioStock: Q4 report points to progress in the clinic for Gabather

    Last week, Gabather published its 2020 year-end report, which shows that the company is ramping up its clinical development with GT-002. Going forward the company will focus on studying the effects of its top candidate on brain activity, which will be a key step in determining dosage of GT-002 to use in future patient studies. BioStock has spoken to CEO Michael-Robin Witt to find out more.Read the full interview with Dr Michael-Robin Witt at biostock.se: https://www.biostock.se/2021/02/q4-report-points-to-progress-in-the-clinic-for-gabather/ This is a press release from BioStock -

    BioStock: Gabather - focus on CNS diseases

    Diseases of the central nervous system (CNS) and mental health issues represent a major burden on society, and there is considerable room for improvements of the current therapeutic alternatives. Swedish pharma company Gabather is working to alleviate this burden by developing therapies targeting the GABA\A \receptor, which is involved in a wide range of CNS illnesses, in particular psychiatric disorders like schizophrenia, depression and anxiety. BioStock got in touch with CEO Dr Michael-Robin Witt to learn more about the company and its strategy for bringing new treatments to CNS disease

    Gabather AB submits a Clinical Trial Application to further advance the development of GT-002

    Gabather’s clinical development with its lead compound GT-002 aims at a Proof-of-Concept (PoC) study addressing cognitive deficits in depression as the first indication. A single-dose target engagement study in healthy volunteers using electroencephalography (EEG) and the safety data acquired from the Multiple ascending dose study (MAD) will guide the design of this efficacy study in patients in an adaptive design. As the next step in this clinical development programme, Gabather AB has today submitted an application to the regulatory authorities in Portugal for the start of a double-

    Gabather AB presents preclinical and clinical data of the Lead Drug Candidate, GT-002, at the American Society for Neurosciences (AfN) meeting in Chicago.

    Gabather AB announces that today the company has a poster presentation summarizing the preclinical and clinical data of GT-002 at the AfN meeting in Chicago. The meeting is the biggest scientific meeting within Neurosciences with more than 26 500 international participants. The presentation includes the preclinical data accumulated during the last years as well as clinical data from the previous phase Ia study in healthy volunteers that was finalized in the second quarter of 2019 (Single Ascending Dose study, SAD). ”We are both proud and happy to present our data and research at this

    Gabather AB expands intellectual property portfolio related to the clinical candidate GT-002

    Gabather AB is pleased to announce a further advance in its intellectual property portfolio.  Gabather’s international Patent Cooperation Treaty (PCT) patent application, submitted in December 2017, related to the improved synthesis process for the large-scale manufacture of triazoloquinazolinones, including its GT-002 clinical drug candidate as WO 2019/123011. The application will next enter the PCT National Phases undergoing examination in individual countries in the EU as well as the USA, India, Japan and China . The filing of PCT national phase patent applications is due by July 2020.

    Gabather has completed toxicological studies

    Gabather AB has successfully completed the regulatory GLP toxicology studies with GT-002 in rodent and non-rodent animal models. The compound was generally safe and well tolerated in repeated dose administrations for 28 days in animals at dose levels that are expected to exceed a therapeutically relevant dose. Furthermore, safety pharmacology was without any remarks, and GT-002 showed no negative cardiovascular treatment-related effects, which are important safety features for further clinical development of GT-002. "These results support moving forward into the clinic in the near future

    Launching a new website.

    Gabather is launching a new website. It will be available through the old URL, www.gabather.com. A new function on the site is enabling users to view the events Gabather will be attending.Gabather will be attending the following upcoming events: -          French Swedish Life Science Day, 20th of October, Paris. -          Shareholder meeting at Erik Penser Bank, 27th of October, Stockholm. -          BIO-Europe, 7-9th of November, Cologne. -          Nordic-American Life Science Conference, 1st of December, New York. -          JP Morgan Healthcare conference, 8-11th of

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