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.

Gabather is a Swedish biotech company developing highly selective small molecular pharmaceutical substances that target the GABAA receptor – a signalling receptor in the central nervous system (CNS) that interacts with one of the most important neurotransmitters in the human brain, gamma aminobutyric acid (GABA). Read a company overview by BioStock here.

Last week, the company released its year-end report, outlining the recent progress in the clinical development of GT-002 and listing potential milestones in the near future.

GT-002 in the clinic

Gabather initiated its clinical development program in 2019, when the company started a phase I clinical study with its top drug candidate GT-002.Thus far, it has proven to have strong anti-psychotic and pro-cognitive properties, that is, an ability to improve memory and cognition. During the last year, after receiving approval from the Portuguese regulatory authorities, Gabather began a phase Ib trial in order to evaluate the safety profile and pharmacokinetic properties in healthy volunteers following multiple and ascending doses (MAD) of GT-002.

In October 2020, Gabather successfully completed the phase Ib study, where the preliminary results showed that the drug candidate has good pharmacokinetic properties and a favourable safety and tolerability profile in healthy individuals. These results were confirmed at the beginning of February this year in a press release reporting on the final analysis of the study.

Next stage of development

In the meantime, Gabather has been preparing a study with the purpose to document the effects of GT-002 in the human brain. In this study, Gabather will utilize functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to confirm that GT-002 passes through the human blood-brain barrier and interacts with its target receptor – GABAA.

»The target engagement study is key in that it shows the modulation of brain activity at both functional and regional levels and it enables us to differentiate GT-002 from other modulators of the GABAA receptor as well as other drugs active in the central nervous system. I expect to see highly selective effects from GT-002 in the study, and, given successful outcomes, an increased interest from potential partners« — Michael-Robin Witt , CEO of Gabather

The target engagement study constitutes a key step in Gabather’s development of GT-002.  In CNS drug development, a well-recognized challenge is to develop pharmaceutical substances with the ability to cross the blood-brain barrier. Therefore, the results from the study will play a fundamental role in the future development with concerns to dose optimisation in future patient studies.

Robust and broad patent protection bedding for future portfolio expansion

Given successful completion of this critical step, Gabather can bring  GT-002 into phase II. With a cash balance of circa 31 MSEK at the end of 2020, the company seems financially well placed for moving forward with confidence in 2021. Additionally, with a TO3 warrant exercise planned in March, the company could rake in another 14 MSEK.

In parallel, the company has been generating positive preclinical results using closely related substances from its early pipeline. The related substances can be developed into new drug candidates with separate patents to broaden the project portfolio, opening up new possibilities for Gabather in several CNS diseases. All substances are protected by two patent families, and additional patent protection exists for GT-002 including formulation, synthetic route and second medical use. For now, Gabather has approved patents and patent applications on the world’s largest markets: Europe, USA, Canada, Japan, China and India. In summary, Gabather has an interesting project portfolio with strong patent protection.

CEO comments on Gabather’s current status

BioStock reached out to Gabather’s CEO Dr Michael-Robin Witt to learn more about the company’s performance last year and its expectations for growth moving forward.

From your point of view, what is the main take-home message from the Q4 report released last week?

– The main take-home message is that we, despite challenges related to the current pandemic, successfully completed the Multiple Ascending Dose study and that we are well on track in the further pipeline development. 

Besides the progress in the clinical development, Gabather also decided to concentrate the company’s activities in Södertälje and close down the Malmö office. What was the purpose of this move, and what impact has it had on company activities?

– Our primary reason to close down the office was to ramp up our R&D activities in the Södertälje lab. The move has also made the operation more efficient as well as reduced the administrative costs to the company.

Michael-Robin Witt, CEO of Gabather

Towards the end of 2020, Gabather made a key recruitment in Kristofer Svensson who was appointed as new Chief Financial Officer. Can we expect to see more recruitments in 2021 as the company expands its clinical development program?

– As the project progresses into more advanced clinical studies we are looking to recruit professionals with medical expertise and experience in clinical development.

Gabather is now entering the target engagement study with GT-002 wherein fMRI and EEG methods will be used to confirm that GT-002 passes through the human blood-brain barrier and interacts with its target receptor. Why is this a key step in the clinical development of CNS drugs and what are your expectations?

– The target engagement study is key in that it shows the modulation of brain activity at both functional and regional levels and it enables us to differentiate GT-002 from other modulators of the GABAA receptor as well as other drugs active in the central nervous system. I expect to see highly selective effects from GT-002 in the study, and, given successful outcomes, an increased interest from potential partners.

Finally, Gabather’s cash position seems strong going into 2021. Plus, a warrant exercise is planned for March of this year. What is your analysis of the company’s financial situation, and do you think it will provide a sufficient cushion for the upcoming activities?

– The upcoming activities have all been budgeted for. Hence, we can move ahead as planned to continue our planned activities.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

 

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