Gabather files two new patent applications to secure novel findings on the effects of GT-002 for the treatment of psychiatric disorders
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Insights
The filing of new provisional patent applications by Gabather AB for their GABAA-receptor modulator GT-002 has significant implications for the company's legal and competitive landscape. The strategy to create a robust intellectual property portfolio is a common and effective one, aimed at safeguarding drug products and ensuring market exclusivity. The patents, if granted, will provide Gabather with legal tools to prevent other companies from entering the market with similar products, potentially leading to a monopoly-like situation for a certain period.
The mention of 'novel and unexpected' claims suggests that the findings from the EEG/fMRI study could be groundbreaking and non-obvious, two key criteria for patentability. However, the true impact on the company's valuation and market position will only be realized if these applications mature into granted patents and if the subsequent clinical trials are successful. The patent applications themselves do not guarantee market success but do indicate a forward-moving trajectory in their R&D pipeline.
From a market perspective, the announcement by Gabather AB represents a strategic move to enhance their market position in the neuropsychiatric drug sector. The focus on building layers of patents around drug products is a tactic to extend the commercial lifecycle of a drug, potentially delaying generic competition and maintaining higher profit margins for a longer period. This is particularly important in the pharmaceutical industry where R&D costs are substantial and the window for recouping these investments is limited by patent life.
Furthermore, the differentiation of their product through proprietary technology could allow Gabather to command a premium price and establish themselves as a leader in a niche market. The announcement also signals to potential partners and investors that Gabather is progressing towards clinical trials, which is a critical milestone in drug development. However, the success of GT-002 and its impact on the company's financials will largely depend on clinical trial outcomes, regulatory approvals and the ability to successfully market and distribute the drug.
The development of GT-002 as a selective positive allosteric GABAA-receptor modulator is noteworthy within the field of neuropharmacology. GABAA receptors are a common target for psychiatric drugs due to their role in modulating neuronal excitability and their involvement in anxiety, depression and other neuropsychiatric conditions. Positive allosteric modulators, by enhancing the receptor's response to the neurotransmitter gamma-aminobutyric acid (GABA), offer a potential therapeutic mechanism without directly activating the receptor, which can reduce side effects.
That said, the path from patent filings to delivering a successful therapeutic to market is fraught with challenges, including rigorous clinical testing for efficacy and safety. The long-term impact on the business will hinge on the clinical trial results and whether GT-002 can demonstrate a favorable safety profile and clinical efficacy compared to existing treatments. If successful, GT-002 could represent a significant advancement in the treatment of psychiatric disorders, which would be a substantial achievement for Gabather and the medical community.
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 GABAA receptor modulators, and the medical use of GT-002. Our IPR strategy is to build layers of patents around our drug products, generating a strong and attractive IPR position for the products that generates an extended patent protection of the drug product. Gabather has an active portfolio of patents and patent applications covering key products and methods that create significant value to the company, giving Gabather the freedom to operate, product differentiation, as well as a strong negotiation position in potential agreement negotiations.
"When approved by USPTO these patent's will further strengthen our drug products and market position, giving Gabather a strong competitive advantage in providing the next generation neuropsychiatric drugs to the patients. 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.
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 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 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. An EEG/fMRI target engagement study in healthy volunteers aimed to determine the effects of GT-002 on brain activity across different brain regions and neuronal networks has recently been completed.
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.
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The following files are available for download:
https://mb.cision.com/Public/11735/3946912/b5e635e909a537a0.pdf | PM patent application 2024-03-18 |
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SOURCE Gabather AB
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