Arrivo BioVentures Reports Positive Findings on SP-624 as Potential First MDD Therapy Targeted to Women
An earlier phase 2 study found statistically significant improvement of MDD in female participants.
Arrivo BioVentures announced positive results from its Phase 2b/3 study highlighting the therapy’s potential to become the first treatment specifically indicated for women with major depressive disorder (MDD), according to a January 10, 2025 company news release.1
SP-624 is a novel sirtuin 6 (SIRT6) activator. During the trial, the SP-624-103 study, SP-624 demonstrated notable alterations in brain activity among healthy participants, suggesting potential benefits for both antidepressant and cognitive outcomes.
“We are encouraged by these findings, which support SP-624’s therapeutic potential in MDD—particularly in women, where there is a critical need for more targeted therapies,” Steve Butts, chief executive officer of Arrivo BioVentures, said in the press release. “The SP-624-103 study provides an early demonstration of central nervous system activity, and we remain optimistic about ongoing trials, including our Phase 2b/3 study.”
An earlier Phase 2 study of SP-624 explored the SIRT6 activator's efficacy over placebo during a 4-week treatment period. In a post-hoc analysis, Arrivo investigators found statistically significant improvement versus placebo consistent across both investigator and patient measures of MDD in women participating in the study, a result achieved as early as week 2, according to the company. In men, there were no statistically significant changes detected.2
“While differences in MDD between males and females have long been discussed, these results support recent published literature citing differences in gene expression between males and females with MDD,” the company wrote in an October 10, 2024 news release.2
The double blind, placebo-controlled phase 2b/3 study is evaluating 3 cohorts. Cohort 1 enrolled 12 healthy participants (8 active treatment, 4 placebo) who received 20 mg of SP-624 during a 15-day period. Quantitative electroencephalography (qEEG) and Firefly Neuroscience’s brain network analytics were used to assess participants on day 1 and day 15, pre- and post-dose. Meanwhile, cohort 2 is actively enrolling 12 patients diagnosed with MDD. The composition of cohort 3 will be determined once Cohort 2 completes enrollment.
Arrivo reported the following results for cohort 1:
- 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,” Joel Raskin, MD, Arrivo Bioventures chief medical officer, noted. “These results may reflect SP-624’s ability to alleviate depressive symptoms by normalizing cortical activity, potentially improving cognitive processing, attention, and cortical arousal.”
References
- Arrivo BioVentures announces positive results from qEEG and BNA™ study of SP-624 on neural brain activity related to depression and cognition. News release. January 10, 2025. Accessed 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
- Arrivo BioVentures begins phase 1 study of SP-624, the first potential treatment specifically for women with major depressive disorder. News release. October 10, 2024. Accessed January 10, 2025. https://www.businesswire.com/news/home/20241010025985/en/Arrivo-BioVentures-Begins-Phase-1-Study-of-SP-624-the-First-Potential-Treatment-Specifically-for-Women-with-Major-Depressive-Disorder
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