Firefly Neuroscience, Inc. (NASDAQ: AIFF), a pioneering AI-driven company specializing in brain health solutions, has announced the use of its FDA-510(k) cleared Brain Network Analytics (BNA™) platform in Arrivo Bioventures’ Phase 1 exploratory study of SP-624. This novel SIRT6 activator is being evaluated for its impact on neurological pathways in patients with Major Depressive Disorder (MDD).
Arrivo’s Phase 1 trial, now underway, explores how SP-624, a first-of-its-kind drug targeting a brain protein called SIRT6, affects cognitive and neurological pathways. The study aims to uncover biomarkers—measurable indicators of drug effectiveness—using Firefly’s BNA™ platform.
The trial builds on earlier research where SP-624 showed impressive results in women with depression. A prior Phase 2 study revealed that female participants experienced significant improvements in symptoms as early as two weeks into treatment, while no meaningful changes were observed in men.
This aligns with growing research suggesting biological differences in how men and women experience depression. The study hopes to clarify these differences further and open new doors for personalized treatment.
Depression is a widespread mental health issue, affecting 21 million adults annually in the U.S. alone. Women are disproportionately impacted, with 10.3% experiencing major depressive episodes compared to 6.2% of men. However, many existing treatments do not account for these gender differences, leaving significant gaps in care.
SP-624’s potential as a targeted treatment for women is particularly exciting, as it addresses an unmet need in mental health care.
Jon Olsen, Firefly’s CEO, stated:
“By integrating our BNA™ platform into this study, we can help Arrivo better understand SP-624’s effects and identify biomarkers that may guide future treatments. Together, we’re advancing mental health solutions, especially for women, who often face unique challenges in managing depression.”
Firefly’s Brain Network Analytics (BNA™) platform uses AI and machine learning to analyze brain activity from EEG tests. With a database of over 17,000 brain scans across various conditions—including ADHD, anxiety, and dementia—Firefly’s technology can detect subtle brain patterns that help predict treatment effectiveness.
Steve Butts, Arrivo’s CEO, emphasized the broader implications:
“Targeting SIRT6 has shown potential in addressing neuropsychiatric, neurodegenerative, and metabolic diseases. This study will expand our understanding of SP-624’s activity and aid in biomarker identification for future applications.”
This partnership could lead to more personalized treatments for depression, particularly for women who haven’t had success with existing options. By using advanced technology to study the brain’s response to SP-624, researchers hope to not only improve depression treatment but also open doors for tackling other brain-related disorders.
About Firefly Neuroscience
Firefly Neuroscience is at the forefront of using AI to improve brain health. Their FDA-cleared BNA™ platform helps doctors and researchers better understand mental health conditions and tailor treatments to individual needs. With over 15 years of research and over 17,000 brain activity scans in their database of brain activity, Firefly is leading the way in combining technology and healthcare to improve outcomes for patients worldwide.
About Arrivo Bioventures
Arrivo Bioventures is a biotechnology company focused on developing novel drug candidates to address unmet medical needs across various therapeutic areas, including neuroscience. Their pipeline includes SP-624, a first-in-class SIRT6 activator being investigated for the treatment of major depressive disorder (MDD). Arrivo collaborates with investors, innovators, and pharmaceutical companies to advance these treatments through clinical development
This partnership highlights the transformative potential of AI in healthcare, not just for advancing research but also for reshaping how mental health conditions are understood and treated.
Are you interested in learning more about AI healthcare? Subscribe to our newsletter, “PulsePoint,” for updates, insights, and trends on AI innovations in healthcare.
