Takeda and Lundbeck revealed new data from four pivotal trials of their antidepressant candidate vortioxetine over the weekend, although only three of them were positive.
The studies are part of a group of eight trials that have been submitted as part of marketing applications for vortioxetine in the US and Europe, with the overall tally standing at seven positive and one negative trial.
Presenting the new data at the American Psychiatric Association (APA) annual meeting in San Francisco, clinicians noted that three studies met the objective of a statistically significant improvement in overall symptoms of depression, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo.
Two of the eight-week studies compared vortioxetine with Lilly’s Cymbalta (duloxetine) as an active control alongside placebo. The negative trial result may have been dose-related. It looked at vortioxetine in 10mg and 15mg daily doses, while the three positive trials used the drug at either 15mg or 20mg/day.
“It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic,” commented Madhukar Trivedi of UT Southwestern Medical Centre in the US, who presented one of the trials at the APA.
“I’m encouraged by these data,” he said. “They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients living with major depressive disorder.”
Vortioxetine is a key pipeline product for both Takeda and Lundbeck, but arguably more so for the latter as it tries to find replacements for big-selling antidepressant Lexapro/Cipralex (escitalopram) that is starting to lose patent protection. The drug brought in 5.83bn Danish kroner (more than $1bn) for the company last year, accounting for almost 40 per cent of its total turnover.
The drug is described as a “multimodal” antidepressant, with a new mode of action that could mean it is effective in patients who do not respond well to current drugs. It acts as a serotonin 5-HT3 and 5-HT7 receptor antagonist, a 5-HT1b receptor partial agonist, a 5-HT1a receptor agonist and an inhibitor of the serotonin transporter SERT.
Analysts have previously suggested that vortioxetine (which has the proposed trade name Brintellix) could achieve sales of $500m within three years of launch, rising to $1.5bn-plus at peak.