Oral ulotaront, being developed by Sunovion Pharmaceuticals, does not act on dopamine D2 receptors but has agonist activity at trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors.
In a prior four-week, randomized, double-blind, placebo-controlled trial, treatment with ulotaront (50 or 75 mg daily) showed significant clinical benefit in adults with an acute exacerbation of schizophrenia (https://bit.ly/3GKD1lc).
After four weeks of treatment, patients taking ulotaront had statistically significant and clinically meaningful improvement in total scores on the Positive and Negative Symptoms Scale (PANSS) - the primary outcome - compared with patients taking placebo (-17.2 vs. -9.7; P=0.001).
Ulotaront also led to significant improvement in several secondary outcomes, including overall illness severity, PANSS positive subscale score, PANSS negative subscale score and PANSS general psychopathology subscale score.
Of the 193 patients who completed the four-week trial, 157 (81.3%) continued into the open-label extension study.
The extension-study results, online now in npj Schizophrenia, show that treatment with ulotaront continued to provide improvements in the PANSS total score - from -17.2 points at the end of the four-week study to -22.6 points at the end of the 26-week extension study.
During the extension study, treatment with ulotaront was associated with continued improvement in depressive symptoms as measured by the Montgomery-Aasberg Depression Rating Scale (MADRS), report Dr. Christoph Correll of Northwell Health, in Glen Oaks, New York, and colleagues.
Ulotaront continued to be well tolerated with a safety profile similar to that observed in the four-week trial.
The most common treatment-emergent adverse events reported in the extension study were schizophrenia (12.2%), headache (11.5%), insomnia (8.3%), and anxiety (5.1%). No clinically meaningful changes were observed on metabolic parameters (including weight, lipids and glucose) or prolactin levels, mirroring the four-week study.
Ulotaront has received breakthrough therapy designation from the U.S. Food and Drug Administration.
"If approved, ulotaront has the potential to be the first treatment with a novel mechanism of action for schizophrenia in more than 60 years," Dr. Robert Goldman, SVP and Chief, Medical Scientific Affairs at Sunovion, told Reuters Health by email.
This study was supported by funding from Sunovion Pharmaceuticals Inc.
SOURCE: https://go.nature.com/3DUfI6I npj Schizophrenia, online December 9, 2021.
By Megan Brooks
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