Arrivo BioVentures Reports Positive SP-624 Study Results on Depression-Related Brain Activity

Arrivo BioVentures, a pharmaceutical company based in Morrisville, N.C., has announced encouraging findings from its SP-624-103 study, which investigates the unique epigenetic mechanism of SP-624 and its effects on neurological pathways. These findings highlight the potential antidepressant and cognitive benefits of SP-624, a SIRT6 activator, which could emerge as the first treatment specifically aimed at women with Major Depression, as indicated by previous research.

The SP-624-103 study is structured as a double-blind, placebo-controlled trial involving three different cohorts. The first cohort included 12 healthy individuals, with 8 receiving the active drug and 4 receiving a placebo over a 15-day dosing regimen. Evaluations such as quantitative EEG (qEEG) and Firefly Neuroscience's Brain Network Analytics (BNA™) were conducted on the first and fifteenth days, both before and after dosing. Currently, the second cohort is in the process of enrolling 12 participants diagnosed with major depressive disorder (MDD), and the composition of the third cohort will be decided following the completion of the second cohort.

The results from the first cohort of the SP-624-103 study revealed several significant findings. Participants demonstrated an increase in beta power, particularly in the frontal-central brain regions, compared to those on placebo after a single dose. This suggests improved synaptic plasticity and neuronal connectivity. Moreover, a decrease in delta power was observed, which is noteworthy because increased delta activity is often linked to decreased cortical arousal and depressive conditions. Additionally, the evoked potential response data suggested enhanced neural efficiency during early perceptual processing, along with faster decision-making and context updating.

Dr. Joel Raskin, Chief Medical Officer of Arrivo BioVentures, explained that the increase in beta power and reduction in delta power signal improved neural synchronization, excitability, and cortical activation. These changes could imply that SP-624 has the potential to relieve depressive symptoms by normalizing cortical activity, which may improve cognitive processing, attention, and cortical arousal. This has significant implications for various neuropsychiatric disorders.

Steve Butts, Chief Executive Officer of Arrivo, expressed optimism about the continued exploration of SP-624 and its SIRT6 mechanism of action. Alongside the ongoing SP-624-103 study, Arrivo is enrolling participants for a Phase 2b/3 study focused on major depressive disorder. The positive data from the current study reinforces the company's belief in the promise of SP-624 for treating MDD and other cognitive disorders.

Arrivo BioVentures is dedicated to developing groundbreaking medicines that address the fundamental causes of challenging diseases, with the aim of delivering meaningful results for patients, thereby improving their quality of life. The company has two promising candidates in clinical development: SP-624 for major depressive disorder and RABI-767 for anticipated severe acute pancreatitis. Situated in Morrisville, N.C., near Research Triangle Park, Arrivo aims to make significant progress in the medical field.

Firefly Neuroscience, a company listed on the NASDAQ (AIFF), is at the forefront of incorporating artificial intelligence to advance brain health solutions for neurological and mental disorders. The FDA-cleared Brain Network Analytics (BNA™) technology, developed by Firefly, is transforming diagnostic and treatment monitoring for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has developed an extensive database of brain wave tests, secured patent protection, and achieved FDA clearance. The company is now commercially launching BNA™, targeting pharmaceutical firms conducting drug research and clinical trials, as well as healthcare providers for clinical use.

Brain Network Analytics combines advanced AI and machine learning with Firefly’s proprietary database of standardized, high-definition longitudinal EEGs from over 17,000 patients across twelve disorders, as well as from clinically normal participants. In conjunction with an FDA-cleared EEG system, BNA™ provides clinicians with detailed insights into brain function, enhancing their ability to accurately diagnose mental and cognitive disorders and determine the most appropriate therapies or drugs to optimize patient outcomes.