Aribio Launches International Joint Clinical Trial of Electroceutical GVD-01 with Support from Austrian Government

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Aribio announced on the 5th that it has officially launched an international joint clinical trial of its independently developed brain-stimulating electroceutical GVD-01 in Austria. GVD-01 is a 40-hertz (Hz) transcranial acoustic vibration stimulation (tVAS) solution designed to treat cognitive impairment and neuropsychiatric symptoms following stroke.

This clinical trial is led by VASCage, which has been designated as a clinical stroke research center in Austria. It is being conducted in collaboration with the Department of Neurology at the Medical University of Innsbruck and is financially supported by the Austrian Research Promotion Agency (FFG).

Aribio plans to evaluate the potential of its low-frequency acoustic vibration headband to improve major neuropsychiatric symptoms commonly observed after stroke, such as depression, anxiety, fatigue, and cognitive decline. Approximately 40 stroke patients will be enrolled in the trial, which will be conducted over three months using a randomized, double-blind, Y-shaped design. Key evaluation endpoints include changes in quality of life (QoL), Hospital Anxiety and Depression Scale (HADS), and Fatigue Severity Scale (FSS) scores.

This study is part of the COMET program, Austria's national research and development (R&D) initiative that supports industry-academia collaboration. The COMET program is operated with the goal of accelerating advanced technology research, promoting industrial innovation, and building a technologically competitive global ecosystem.

The VASCage research center is a specialized clinical stroke research institution designated within the COMET program, which is supported by the Austrian Federal Ministry for Economy, Energy and Tourism, the Federal Ministry for Innovation, Transport and Infrastructure, and the states of Tyrol, Vienna, and Salzburg.

Co-principal investigators Professor Michael Knoflach and Professor Atbin Jamshidian Tehrani of the Medical University of Innsbruck said, "Aribio's wearable solution based on low-frequency stimulation offers a new therapeutic approach that can complement and enhance existing pharmacological treatments," adding, "We expect this clinical trial to provide scientific evidence on the safety and efficacy of the device for stroke patients."

Jae Young Ha, Executive Vice President and Head of Research Business Development at Aribio, said, "This international clinical trial is an important milestone in validating the potential of non-invasive wearable neurostimulation technology to improve the quality of life of stroke patients," and added, "Based on the clinical data obtained, we will swiftly pursue entry into global markets, including Europe."

Aribio is rapidly expanding its portfolio for the treatment of degenerative brain diseases by accelerating its global expansion not only with AR1001, an oral Alzheimer's disease treatment currently in Phase 3 clinical trials in 13 countries, but also in the field of brain-stimulating electroceuticals. The company explained that, through its Two-Track strategy encompassing both pharmaceutical and non-pharmaceutical products, it has secured key competitiveness to lead the global market for treatments of dementia and degenerative brain diseases.

Meanwhile, Aribio is pursuing a merger with KOSDAQ-listed company Solux, with the scheduled merger date set for May 7.

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