Study will identify target engagement and biomarkers that can be used in future studies across a variety of neurological conditions, and assess changes in various cognitive domains in subjects with MDD
An earlier Phase 2 study demonstrated that female subjects on SP-624 experienced early and robust alleviation of depressive symptoms versus male patients in the study
MORRISVILLE, N.C.--(BUSINESS WIRE)--Arrivo BioVentures announced today that it has enrolled the first subject in a Phase 1 exploratory study of the company’s first-in-class SIRT6 activator, SP-624, in healthy volunteers and patients with major depressive disorder (MDD). The study is designed to evaluate the impact of the epigenetic mechanism of action of SP-624, on neurological pathways and assess changes in various cognitive domains. SP-624 is also currently being studied in a large Phase 2b study in patients diagnosed with MDD, with efficacy in females as the primary endpoint.
In an earlier Phase 2 study of SP-624, Arrivo explored efficacy over placebo during a 4-week treatment period. In a post-hoc analysis, the company found statistically significant improvement versus placebo consistent across both investigator and patient measures of MDD in female subjects, which was achieved as early as Week 2. In male subjects, there were no statistically significant changes detected. 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.
Using Firefly Neuroscience’s BNA™ technology, Arrivo will also identify target engagement and biomarkers in the Phase 1 study that can be used in future studies across a variety of neurological conditions, including MDD.
“There is a growing body of literature suggesting that targeting SIRT6 can play an important role in multiple neuropsychiatric, neurodegenerative, inflammatory, and metabolic diseases,” said Steve Butts, CEO of Arrivo. “This study should help us in our on-going efforts to characterize the activity of SP-624 and look for potential biomarkers.”
In addition, the study will evaluate potential changes in cognition. Cambridge Cognition’s CANTAB® Cognitive Test Battery will be used to assess these changes in the subjects with MDD.
“Cognitive impairment is debilitating to many patients suffering from MDD,” said Dr. Joel Raskin, Chief Medical Advisor at Arrivo. “By assessing the effect of SP-624 on multiple cognitive domains, we hope to replicate the positive impact on cognitive impairment seen in animal models.”
The Phase 1, single-center, double-blind, randomized, placebo-controlled study is being conducted at Alivation Research with Walt Duffy, M.D., founder, CEO and Chief Medical Officer, as the Principal Investigator.
“For many patients, an initial episode of depression can evolve into a recurrent and debilitating chronic illness. While there are many antidepressants available today, there remains a significant unmet need for new therapeutics that can achieve a faster onset of action, better efficacy and less side effects,” said Dr. Duffy. “We look forward to studying SP-624, with its novel epigenetic SIRT6 mechanism of action, which could represent a promising new approach to improving patient outcomes.”
About Arrivo BioVentures
Arrivo BioVentures is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.
Contacts
Media Contact for Arrivo Bio
Alexis Feinberg
Vice President, ICR Healthcare
Alexis.feinberg@westwicke.com
