Exploratory Study Shows Promise of SP-624 for Improving Depression, Cognition

In an exploratory study, SP-624 showed promise in treating depression symptoms and cognition, announced by Arrivo BioVentures on January 10, 2024. Backed with the positive data, SP-624 has the potential to be the first treatment specifically for females with Major Depressive Disorder (MDD).

“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,” said Steve Butts, chief executive officer at Arrivo BioVentures, in a statement.

SP-624, a SIRT6 activator, has a novel epigenetic mechanism of action on neurological pathways. Investigators studied the drug in a double-blind, placebo-controlled study of 12 healthy subjects who received either 20 mg of SP-624 (n = 8) or placebo (n = 4) over a 15-day dosing period.

The team performed quantitative EEG and Firefly Neuroscience’s brain network analytics on day 1 and day 15 (post-dose). This trial will also include 2 other cohorts—cohort 2 is actively enrolling 12 patients diagnosed with MDD, and cohort 3 will be determined once cohort 2 completes the trial.

Although all the patients in cohort 1 were healthy subjects, investigators discovered an increase in beta power in the frontal-central regions after a single dose among patients assigned to SP-624 compared to those assigned to placebo. This finding suggests that SP-624 enhances synaptic plasticity and neuronal connectivity.

Moreover, participants on SP-624 had a decrease in delta power. This was a notable finding since increases in delta activity are often linked to reduced cortical arousal and depressive states.

“An increase in beta power and decrease in delta power are indicative of enhanced neural synchronization, excitability, and cortical activation,” said Joel Raskin, Arrivo BioVentures’ chief medical officer, in the press release. “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.”

The evoked responses indicated a neural efficiency in early perceptual processing and improved decision-making and context speed.

“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,” Butts said.

References

Arrivo BioVentures Announces Positive Results from qEEG and BNA™ Study of SP-624 on Neural Brain Activity Related to Depression and Cognition. Business Wire. January 10, 2025. https://www.businesswire.com/news/home/20250110201020/en/Arrivo-BioVentures-Announces-Positive-Results-from-qEEG-and-BNA%E2%84%A2-Study-of-SP-624-on-Neural-Brain-Activity-Related-to-Depression-and-Cognition. Accessed January 10, 2025.