Firefly Neuroscience's Brain Network Analytics Used in Phase 1 Study of SP-624 for Women's Major Depressive Disorder

Firefly Neuroscience, Inc. (NASDAQ: AIFF), a company renowned for its AI-driven solutions to enhance brain health, has announced that its FDA-cleared Brain Network Analytics (BNA™) platform will play a crucial role in Arrivo Bioventures' Phase 1 exploratory study of SP-624, a SIRT6 activator. This study will include both healthy volunteers and patients suffering from major depressive disorder (MDD), aiming to understand the epigenetic impact of SP-624 on neurological pathways and its effect on various cognitive areas.

Firefly’s BNA™ technology is developed to discover biomarkers, and this partnership will enable Arrivo to better comprehend the activity of SP-624. The study aims to uncover critical biomarkers, which could be pivotal for future neurological research. Jon Olsen, CEO of Firefly, emphasized the importance of this collaboration in advancing treatments for women with MDD, highlighting the unmet needs in mental health.

SP-624 has shown promising results in previous studies, particularly in women. An earlier Phase 2 study exhibited significant improvements in women compared to placebo as early as the second week of treatment. However, no significant changes were observed in men. These findings support existing literature on gender differences in gene expression in MDD. The current study with Firefly aims to validate these results further and identify biomarkers that can be used in future research on neurological conditions, including MDD.

Steve Butts, CEO of Arrivo, pointed out the potential of targeting SIRT6 in various diseases, including neuropsychiatric and neurodegenerative disorders. He believes this study will help characterize the activity of SP-624 and identify potential biomarkers that can be beneficial in broader neurological research.

The Phase 1 study is a single-center, double-blind, randomized, placebo-controlled trial being conducted at Alivation Research, with Dr. Walt Duffy serving as the Principal Investigator. This study is a significant step in exploring the potential of SP-624 and leveraging Firefly’s advanced BNA™ technology for biomarker identification.

Firefly Neuroscience, with its innovative AI-powered solutions, aims to revolutionize the diagnosis and treatment monitoring for various neurological and mental disorders. Their Brain Network Analytics platform utilizes an extensive database of brain wave tests to provide clinicians with detailed insights into brain function. This technology is expected to enhance diagnosis accuracy and optimize treatment outcomes for patients with conditions such as depression, dementia, anxiety disorders, concussions, and ADHD.

Firefly’s comprehensive database, which includes high-definition longitudinal electroencephalograms (EEGs) from over 17,000 patients, has been instrumental in developing BNA™. This platform, combined with an FDA-cleared EEG system, offers clinicians a valuable tool for understanding brain function and tailoring treatments to individual patient needs.

Arrivo Bioventures, based in Morrisville, N.C., is dedicated to addressing unmet medical needs by partnering with investors, innovators, and pharmaceutical companies. Their portfolio includes diverse drug candidates with the potential to be first-in-class or best-in-class, aiming to improve the lives of millions of patients worldwide.

This collaboration between Firefly and Arrivo marks a significant milestone in neurological research, potentially leading to breakthroughs in understanding and treating major depressive disorder and other brain-related conditions.