Arrivo Bio initiates phase 2b trial of SIRT6 activator for major depressive disorder

Key takeaways:

• The clinical trial of SP-624 is expected to enroll 450 patients with major depressive disorder.
• The primary endpoint will be the change from baseline on the Montgomery-Åsberg Depression Rating Scale.

Arrivo Bio has dosed the first patient in a phase 2b clinical trial of SP-624, a novel SIRT6 activator being evaluated as a treatment for major depressive disorder, the company announced in a press release.

“Arrivo is at the forefront of clinical research with SIRT6 activators,” Arrivo co-founder and CEO Steve Butts, MBA, told Healio. “We have spent years learning about this important new target. The SIRT6 enzyme is captivating the medical community across many disease spaces, and we are excited by the promising research in depression.”

According to the release, the study will enroll 450 patients with MDD and assess the effectiveness of SP-624 compared with placebo. The change from baseline on the Montgomery-Åsberg Depression Rating Scale serves as the study’s primary endpoint.

In addition, the large trial size will allow for the exploration of several other investigator- and patient-rated endpoints and exploratory biomarkers, the release stated.

“Mental health is a growing epidemic, and we hope our unique treatment will bring relief to those who are battling major depressive disorder in the future,” Butts said.