Depression treatment shows ‘robust efficacy’ in women in phase 2 trial

Arrivo BioVentures, a biopharmaceutical company, has announced preliminary results from a randomized, placebo-controlled phase 2 clinical trial of SP-624, a first-in-class, sirtuin 6 activator for the treatment of major depressive disorder.

According to a press release from Arrivo, trial results were not significant on the primary endpoint for all study participants, but showed “robust efficacy” in women after the 4-week treatment period.

Women represented two-thirds of the study population, with 205 of 319 participants. Patients were given either 20 mg of SP-624 or placebo daily for 4 weeks.

After 4 weeks, the change in baseline on the Montgomery-Asberg Depression Rating Scale was greater in those taking SP-624 compared with those who received placebo, with a mean reduction of 3.9 points. In addition, 25% of women achieved remission after 4 weeks, and 38% of women achieved a clinical response.

“While more studies are needed, based on its novel mechanism, early and increasing efficacy seen by both patients and investigators, along with the benign adverse event profile seen in the study, SP-624 has the potential to be an important new treatment for major depressive disorder,” Arrivo psychiatry consultant Joel Raskin, MD, FRCPC, said in the release.

Arrivo reported in the press release that SP-624 was well tolerated. The most common adverse events reported were headache and nausea. None of the study participants needed a dose reduction due to tolerability issues.