Science and Technology

Breakthrough in Neuropsychiatric Treatment: Gabather AB Announces Promising GT-002 Study Results

In a recent revelation from Stockholm on March 7, 2024, Gabather AB, a pioneer in the pharmaceutical industry listed on the Nasdaq First North Growth Market (GABA), has unveiled encouraging initial findings from its cutting-edge research. The company’s latest study revolves around the GT-002, a GABA_A-receptor positive allosteric modulator, which has undergone an advanced phase Ib target engagement study. This study deployed electroencephalogram (EEG) and functional Magnetic Resonance Imaging (fMRI) to evaluate the drug’s effect in healthy volunteers.

Gabather’s Groundbreaking Phase Ib Study Outcomes

The clinical study was meticulously designed as double-blinded and placebo-controlled, with a cross-over configuration, securing the integrity and reliability of the results. Gratifyingly, the research fulfilled its primary aim by ascertaining a positive safety and tolerability profile for GT-002. A secondary, yet equally compelling objective to display target engagement within the human brain has similarly been attained. The data has distinctively shown that GT-002 administers a robust safety profile and is well tolerated in dosage regimes which are deemed efficacious for treating patients with neuropsychiatric disorders.

GT-002 Exhibits Clinically Relevant Modulation of Brain Activity

Gabather AB’s study has observed clinically significant effects of GT-002 on the modulation of EEG frequency band power. Notably, there was a substantial uptick in alpha band power in subjects treated with GT-002—especially when contrasted with Lorazepam, a well-known sedative, at the 2-hour post-treatment mark. These shifts in brain activity spread across various brain regions, including the frontal and occipital areas. In sharp contrast, Lorazepam did not manifest any notable influence on EEG alpha band power when held up against the placebo. These results highlight GT-002’s unique capability to modulate alpha band power across precise cortical regions.

The Significance of EEG Alpha Band Power

EEG alpha band power stands as a renowned indicator of cognitive processes like attention and is tied to a state of relaxation and diminished anxiety. An elevation in alpha band can be propitious for an assortment of neuropsychiatric conditions. The study's outcomes hold particular significance for schizophrenia, as reports have indicated a correlation between the disease’s negative symptoms and diminished EEG alpha band power.

Executive Insight into GT-002's Future

Michael-Robin Witt, the CEO of Gabather AB, has radiated optimism on the future of GT-002 after the clinically relevant brain target engagement was demonstrated following oral administration. “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," Witt elucidated with a forward-looking perspective.

An In-Depth Look at GT-002

GT-002's scientific profile is impressive, acting as a Positive Allosteric Modulator (PAM) of the GABA_A receptor which evokes both tonic and phasic inhibitory currents. The small molecule has demonstrated promising effects in preclinical models, enhancing learning and memory capacities. It has effectively reversed cognitive deficits instigated by ketamine in a discrimination learning task model and has inhibited behavioral impacts induced by phencyclidine in an in-vivo model analog to schizophrenia.

Furthermore, GT-002 has showcased an anxiolytic effect and increased social interaction in rats, pointing towards its potential benefits for anxiety and social disorders. Its unique binding site on the GABA_A receptors is different from traditional benzodiazepines, which notably does not share the usual side effects familiar with that class of drugs. Encouragingly, a long-term treatment study indicated that there are no withdrawal symptoms or drug abuse liability with GT-002. To date, the molecular compound has completed three phase I clinical trials with healthy volunteers. These trials, which included both single ascending dose (SAD) and multiple ascending dose (MAD) studies, have verified that GT-002 has a commendable safety profile, excellent pharmacokinetic properties, and the potential for once-a-day oral dosing.

Gabather’s Dedication to Mental Health Innovation

Gabather, as a clinical-stage pharmaceutical company, is immersed in the endeavor to revolutionize the treatment landscape for neuropsychiatric disorders. Establishing its foundation to cater to the considerable demand for innovative treatment options, the company projects development of novel therapeutics encompassing a broad range of neuropsychiatric ailments. Amidst a horizon where traditional therapies have lagged, Gabather’s mission stands to introduce groundbreaking medicines that will shape the future of clinical therapy, aiming to realize a significant impact on patient well-being.

For those interested in learning more about Gabather and its ambitious mission, additional information is accessible at their website, which can be visited at www.gabather.com.

Contacting Gabather’s Leadership and Advisory Team

Gabather AB makes it simple for stakeholders and interested parties to reach out. Michael-Robin Witt, the driving force behind the company's visionary leadership, readily provides his contact information for direct communication. He can be reached via phone at 073-687 28 39 or through email at [email protected] Moreover, Gabather's partnership with Corpura Fondkommission AB as their Certified Adviser offers another channel for corporate governance queries and investor relations.

Forward-Thinking and Future Prospects

Exuding confidence, Gabather’s representatives have expressed that the recent press release constitutes forward-looking statements which embody optimistic estimates and forecasts for the future. As with any progressive research within the biotech realm, such projections are inherently paired with risks and uncertainty. Therefore, while today’s assertions are made with the best available knowledge, the actual results could significantly deviate from those discussed.

Files Available for Further Information

To underpin the transparency of its research and development, Gabather AB has made available files for download that provide further details on the positive clinical data related to GT-002. These documents act as a testament to Gabather's adherence to scientific rigor and its commitment to keeping stakeholders informed.

The following resources are available for download, which contain comprehensive information and findings:

• PM Positive Clinical Data GT-002 2024-03-07

Final Considerations

In summary, the disclosed study by Gabather AB not only signifies a significant stride in neuropharmacology but also instills hope for the countless individuals grappling with neuropsychiatric conditions. The compelling results of the GT-002 study provide a glimpse into the promising future of a treatment that is safe, effective, and devoid of the adverse effects often associated with current medications. With the next phase of trials looming on the horizon, the medical community eagerly anticipates the evolution of GT-002, poised to occupy a pivotal role in the landscape of neuropsychiatric therapeutics.

As research progresses, it will be critical to monitor the outcomes and implications of the forthcoming clinical trials involving patients. With Michael-Robin Witt's leadership and Gabather’s commitment to innovation and therapeutic advancement, GT-002 could potentially reshape our approach to mental health treatment and offer solace to those in need.

In an era where mental health is at the forefront of global health discussions, the clarity provided by EEG and neuroimaging techniques in assessing cognitive function and therapeutic efficacy marks a revolutionary step. Gabather AB embodies the spirit of scientific excellence and offers a beacon of hope for the next generation of neuropsychiatric care.

As we await further developments from Gabather AB, their pioneering work serves as a reminder of the relentless pursuit of innovation and the tireless efforts to improve patient outcomes. The journey of GT-002 from a molecular hypothesis to a potential therapeutic reality reflects the essence of advanced biopharmaceutical research, overcoming challenges and bridging the gap between the lab and the clinic.

With patient care as the ultimate goal, Gabather AB continues to advance with unwavering dedication and a forward-looking vision. Their journey illustrates the potential inherent in the pharmaceutical industry to revolutionize the treatment of conditions that have long challenged clinicians and patients alike.

In conclusion, the ongoing saga of GT-002 is more than a mere scientific endeavor—it's a narrative of hope and determination. As the details unfold and clinical trials progress, the world watches on with bated breath, optimistic about the potential of this promising new candidate to change the face of mental health treatment.