Definium Therapeutics, Inc. (DFTX) on Monday reported positive topline results from its Phase 3 Emerge study evaluating a single dose of DT120 orally disintegrating tablet (ODT) in adults with major depressive disorder. The company's shares rose more than 30% in pre-market trading.
The Emerge trial met its primary endpoint, showing a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week six.
Patients who received DT120 ODT recorded a least squares mean reduction of 13.3 points from baseline in the MADRS total score, a measure of depression severity, compared with a 5.2-point reduction for placebo recipients.
The company said DT120 ODT was generally well tolerated, with 99% of treatment-emergent adverse events classified as mild to moderate in severity. Most adverse events were transient and occurred on the day of dosing.
No new safety signals were identified, including no increase in suicidal ideation or behavior, while discontinuation rates were low and comparable between the treatment and placebo groups.
Definium shares closed at $24.48 on Friday, up 0.20%.
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