Gabather AB reported 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 the company's 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.

The company's IPR strategy is to build layers of patents around the company's 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. 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.