Axsome Therapeutics Inc. said its medicine AXS-05 helped reduce depression symptoms in patients and met the main goal of a mid-stage study.
The New York-based biopharmaceutical company's stock was up by 211.79% on Nasdaq to $8.20 as of 12:18 p.m. ET on Jan. 7, 2019, following the news.
A phase 2 trial called Ascend evaluated AXS-05 against standard antidepressant therapy bupropion in 80 patients with major depressive disorder, or MDD, which affects an estimated 16 million Americans each year.
The company said about 23% of the total patients had received prior antidepressant therapy.
After 6 weeks of treatment, the medicine showed a 17.2 point reduction in depression severity on the Montgomery–Åsberg Depression Rating Scale, or MADRS — more than the 12.1 point reduction for those taking bupropion. The scale is used by psychiatrists to measure the severity of depressive episodes in patients with mood disorders.
About 47% of patients who received AXS-05 saw a reduction in their disease severity, defined as a score of 10 or less on the MADRS, compared to 16% of patients who received bupropion.
Patients on AXS-05 also demonstrated statistically significant effects compared to bupropion on the Clinical Global Impression-Severity Scale — a 7-point scale that measures the severity of symptoms of a patient's illness.
The company said it plans to meet with the U.S. Food and Drug Administration to define the potential regulatory path for the broader MDD population. The detailed results of the trial are expected to be presented at upcoming scientific meetings.
AXS-05, which received the fast-track designation from the U.S. FDA for treatment-resistant depression, is also being evaluated in a phase 3 trial known as Stride-1 to treat patients with major depressive disorder who failed one or two prior antidepressant therapies.