Cheerful mid-stage depression drug data send Axsome stock flying

On the same day Sage rolled out $SAGE tremendous oral drug data in postpartum depression, Axsome Therapeutics has announced that its lead experimental CNS drug induced statistically significant improvements in patients with major depressive disorder (MDD) in a mid-stage study, prompting the company’s stock $AXSM to skyrocket more than 150% in pre-market trading on Monday.

In general, trials testing depression drugs are notoriously tricky and prone to failure, in major part due to high rates of the placebo effect.

The pill AXS-05, which consists of a combination of dextromethorphan (DM) and bupropion, was tested against bupropion alone in 80 MDD patients for 6 weeks in the mid-stage ASCEND study. Data showed the company’s drug induced a statistically significant reduction on the Montgomery-Åsberg depression rating scale, averaged over the 6-week treatment period versus bupropion (p<0.001), and its superiority over the comparator treatment had begun to emerge from week 1, culminating in statistical significance in week 2, the company said.

At week 6, AXS-05 demonstrated a 17.2 point reduction on the scale, compared to a 12.1 point reduction for bupropion (p=0.013).

Raghuram Selvaraju

These data bode well for the pill, which is currently being evaluated in a Phase III trial — dubbed STRIDE-1 — for treatment-resistant depression (TRD), wrote H.C. Wainwright’s Raghuram Selvaraju in a note, raising his probability of TRD approval from 30% from the prior 15%.

We view these data as highly encouraging, particularly given the relatively small size of the trial; AXS-05’s clear separation from bupropion underscores the differentiated profile of Axsome’s candidate…the positive efficacy seen in the ASCEND study should bolster investors’ confidence in the outcome of STRIDE-1, which could position AXS-05 further as a differentiated next-generation therapeutic approach for depression.

In the ASCEND study, AXS-05 was found to be superior to bupropion across all secondary endpoints, with statistically significant effects demonstrated on most measures. Overall, the rate of adverse events was similar in either arm, and there were no side-effects of weight gain or sexual dysfunction — typically observed with antidepressant use — associated with AXS-05.

Topline results from the ongoing STRIDE-1 are anticipated later this quarter. The drug, which has been granted fast track status by the FDA, is also being tested as a treatment for agitation associated with Alzheimer’s and smoking cessation.

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