Please ensure Javascript is enabled for purposes of website accessibility

Axsome Therapeutics' Key Drug Candidate Whiffs in Phase 3 Trial

By Taylor Carmichael - Mar 30, 2020 at 12:35PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The company's depression drug AXS-05 failed to meet its primary endpoints in the study, although it did hit the secondary endpoints.

Axsome Therapeutics (AXSM 8.57%) on Monday released the data from its phase 3 trial for AXS-05 in patients suffering from treatment-resistant depression (TRD), and it was not quite what the company had hoped for. AXS-05 failed to achieve its primary endpoint in the study, although it did show efficacy in its secondary endpoint. 

The study of 312 patients with confirmed TRD, all of whom had all failed two or three prior treatments for depression, compared AXS-05 to bupropion (Wellbutrin). The primary endpoint was whether the patients had significantly improved symptoms (as measured by the Montgomery-Asberg Depression Rating Scale, or MADRS) after six weeks of treatment. While those patients taking Axsome's drug did slightly better than those on bupropion, the difference was not statistically significant.  

woman in silhouette

Image source: Getty Images

On the positive side, the company reported that AXS-05 met its secondary endpoints in the study. The drug was statistically superior to bupropion after one week of treatment (a score of 5.2 versus 3.6 on the MADRS), and after two weeks of treatment (a score of 8.0 versus 6.1). And while the two drugs had similar efficacy at the six-week point, on average during the six weeks of treatment, AXS-05 was statistically superior to bupropion. 

Axsome Therapeutics was the best-performing stock of 2019, when it jumped by an astounding 3,600%. Much of the market's enthusiasm for the company was due to AXS-05. In a phase 3 trial for major depressive disorder (MDD), Axsome's drug passed with flying colors, and the stock took off.

The company is seeking FDA approval for AXS-05 to treat multiple indications, including major depressive disorder, treatment-resistant depression, agitation in Alzheimer's disease, and smoking cessation. While Monday's news about TRD patients is disappointing (the stock was down more than 9% in early afternoon trading), the drug remains on track to be approved for the MDD indication.    

Taylor Carmichael owns shares of Axsome Therapeutics. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Axsome Therapeutics, Inc. Stock Quote
Axsome Therapeutics, Inc.
$43.44 (8.57%) $3.43

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/07/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.