Arrivo Bioventures' depression med failed to improve symptoms in a phase 2 study, but the company is spinning the results as a positive outcome by pointing to promise specifically in women.
The Jazz Pharmaceuticals-backed biotech said Monday that the asset, SP-624, failed to improve symptoms compared to placebo across all trial participants. But the company argued that the drug—which is designed to activate the SIRT6 enzyme—worked specifically in women, who made up two-thirds of the trial population.
As early as three weeks after treatment, the drug was found to make a statistically significant reduction in symptoms in female participants compared to placebo and that after four weeks, the separation grew, Arrivo said. In addition, 25% of the 205 women who received SP-624 achieved remission and 38% achieved a clinical response.
“We look forward to unlocking the potential of SIRT6 activation to help millions of females struggling with depression and other conditions, starting with phase 3 studies of SP-624 that are expected to commence in 2023,” CEO Steve Butts said in a release.
In a subsequent interview with Fierce Biotech, Butts said the company is considering recruiting both men and women for a registrational phase 2/3 study, but only including women in the primary endpoint of reduced symptoms.
"That seems to be the best way to go," he said. "We want to make sure that we're following through and making sure that we continue to validate what we're seeing here."
The topline data is the most robust taste of clinical results since the company emerged in 2016 with $49 million in financing, led by Jazz Pharmaceuticals. The company then went into apparent hibernation until December 2021, when it unveiled its pipeline and teased promising phase 1 data of another asset, DLX-2323, to treat inflammatory disease.
Arrivo’s other early-stage asset, DLX-105, was slated to read out in patients with plaque psoriasis by the second quarter of this year, but the company has yet to release any data. Butts conceded that the asset, which combines a micro-needle patch with antibody fragments, has "taken a little bit of work" to formulate and the company is just now collecting the data. He estimated data would be available in early 2023.
The company's depression data comes two months after Axsome nabbed FDA approval for its own med, the first for a fast-acting oral treatment of the disease. Whereas most depression medications take weeks to kick in, Axsome touted Auvelity’s ability to show benefits within a week.
Editor's note: This story was updated at 5:15 p.m. ET to include editorial from an interview with Arrivo CEO Steve Butts.