Arrivo BioVentures Announces Positive Results from qEEG and BNA Study of SP-624 on Neural Brain Activity Related to Depression and Cognition

Business Wire 10-Jan-2025 8:00 AM

Findings show significant brain activity after a single 20mg dose of SP-624 in healthy subjects

Phase 2b/3 study of SP-624 in major depressive disorder is underway

SP-624 has the potential to be the first treatment specifically for females with Major Depression

Arrivo BioVentures today announced positive data from its SP-624-103 study evaluating the impact of SP-624's novel epigenetic mechanism of action on neurological pathways. The findings provide insights into the potential antidepressant and cognitive effects of SP-624, a SIRT6 activator that may be the first treatment specifically for females with Major Depression based on previous studies.

Arrivo's SP-624-103 study is a double blind, placebo-controlled study with three cohorts. Cohort 1 is comprised of 12 healthy subjects (8 active, 4 placebo) who received 20mg of SP-624 over a 15-day dosing period. Assessments, including quantitative EEG (qEEG) and Firefly Neuroscience's ((AIFF) brain network analytics (BNA™), were performed at Day One and Day 15 pre- and post-dose. Cohort 2 is actively enrolling 12 patients diagnosed with major depressive disorder (MDD). The subject composition of the 3^rd cohort will be determined after the completion of the second cohort.

Cohort 1 results of the SP-624-103 study include:

• Subjects showed an increase in beta power, particularly in the frontal-central regions compared to patients taking placebo after a single dose, suggesting enhanced synaptic plasticity and neuronal connectivity.
• Subjects showed a decrease in delta power. This is important as increases in delta activity are often associated with reduced cortical arousal and depressive states.
• Evoked potential response findings suggest enhanced neural efficiency in early perceptual processing and improved decision-making speed and context updating.

"An increase in beta power and decrease in delta power are indicative of enhanced neural synchronization, excitability and cortical activation," said Arrivo BioVentures Chief Medical Officer Dr. Joel Raskin. "These findings could be indicative of SP-624's ability to alleviate depressive symptoms by normalizing cortical activity, potentially improving cognitive processing, attention and cortical arousal, with implications for numerous neuropsychiatric diseases."

"We are continuing to explore the possibilities with SP-624 and the SIRT6 mechanism of action in this trial along with a Phase 2b/3 study for major depressive disorder that we are currently enrolling," said Arrivo Chief Executive Officer, Steve Butts. "The SP-624-103 study provides solid evidence that we have an active drug in the central nervous system and increases our confidence in the potential of SP-624 in MDD and other cognitive disorders."

About Arrivo BioVentures Arrivo is developing first-of-its-kind medicines that target the root cause of hard-to-treat diseases with the goal of achieving meaningful outcomes for patients, allowing them to live longer, healthier lives. Arrivo has two clinical-stage pipeline candidates, SP-624 for major depressive disorder and RABI-767 for predicted severe acute pancreatitis. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.

About Firefly Firefly (NASDAQ:AIFF) is an Artificial Intelligence ("AI") company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.

Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly's extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician's ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient's outcome.

Please visit https://fireflyneuro.com for more information.

*BNA™ is a trademark of Firefly Neuroscience, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250110201020/en/

Media Contact for Arrivo Bio Alexis Feinberg Vice President, ICR Healthcare Alexis.feinberg@westwicke.com