Closely held Arrivo BioVentures has announced promising results from its study evaluating SP-624’s novel epigenetic mechanism of action on neurological pathways.
According to the company, the findings provide insights into the potential antidepressant and cognitive effects of SP-624, a SIRT6 activator that may represent the first treatment specifically targeting females with major depression, as suggested by previous studies.
The SP-624-103 study is a double blind, placebo-controlled trial consisting three cohorts.
Cohort 1 comprises 12 healthy subjects (eight receiving SP-624, four receiving placebo) who were administered 20mg of SP-624 over a 15-day dosing period. Assessments—including quantitative EEG (qEEG) and Firefly Neuroscience’s (NASDAQ: AIFF) brain network analytics (BNA)—were conducted on days one and 15, both pre- and post-dose.
Cohort 2 is actively enrolling 12 patients diagnosed with major depressive disorder (MDD).
The subject composition of the third cohort will be determined after the completion of the second cohort.
Cohort 1 Results:
Key findings from 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 Dr. Joel Raskin, CMO of Arrivo. “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.”
Steve Butts, CEO of Arrivo, added, “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. 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.”
In response to a BioTuesdays request for comment on Arrivo’s announcement, Firefly’s executive chairman, Greg Lipschitz, said, “We would like to congratulate the Arrivo BioVentures team on these exciting SP-624-103 study results. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA) technology, employed in the study, was developed using artificial intelligence and machine learning on our extensive proprietary database of standardized, high-definition longitudinal EEGs of over 17,000 patients representing twelve disorders, as well as clinically normal patients. As the study progresses, we look forward to Arrivo BioVentures continuing to use BNA to help better understand SP-624’s event-related potential.”
