Arrivo Bio Initiates Large Phase 2b Clinical Trial in Major Depressive Disorder with Novel SIRT6 Activator

Arrivo Bio announced today a significant step forward in the fight against major depressive disorder (MDD) with the dosing of the first patient in the SP-624-202 clinical trial.

This registration-quality Phase 2b study will enroll 450 subjects with MDD and evaluate the effectiveness of SP-624, a SIRT6 activator and novel mechanism of action, compared to placebo in treating adults with Major Depressive Disorder. The SP-624-202 study will assess the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) as its primary endpoint. The MADRS is a 10-item depression rating scale commonly used to assess the severity of depression in clinical trials. The large number of subjects will enable the study to explore several other investigator and patient-rated endpoints and exploratory biomarkers.

SIRT6 is an enzyme that plays an essential role in human health and contributes to epigenetic regulation of gene expression, mitochondrial health, and DNA repair. A review of literature suggests that SIRT6 could potentially help address diseases of aging, neurodegeneration, diabetes and obesity, in addition to depression. Arrivo is exploring the potential of SP-624 in multiple therapeutic areas beyond depression.

"The initiation of this study is an exciting milestone for Arrivo and the SP-624 program. Despite existing treatments, people with Major Depression often do not achieve remission and suffer unwanted side effects," said Dr. Joel Raskin, Chief Medical Advisor at Arrivo. "This large study will significantly augment our current data on SP-624, which has the potential to be a truly transformative treatment for patients suffering from depression."

Arrivo remains committed to advancing groundbreaking research in MDD and looks forward to sharing further developments from the SP-624-202 study. For more information on Arrivo or the SP-624-202 study, please visit www.arrivobio.com

About Arrivo BioVenture LLC

Arrivo 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.