The chief doctor at a $2.7 billion pharmaceutical company developing a new depression drug says we may be ‘on the cusp’ of a new wave of mental health treatments

A sad young woman sitting on the window, looking out

Sad young woman sitting on the window, looking out – stock photoTunatura/Getty Images

  • Most depression treatments do not work quickly and are meant to be taken for long periods of time.

  • Sage Therapeutics is developing a fast-acting drug that patients take for two weeks.

  • Dr. Laura Gault told Insider that psychiatry is about to have new and better medications.

Years ago, only psychiatry was left to Big Pharma. After undertaking large, disappointing, failed trials that they hoped would lead to new and profitable treatments, major companies put together their ambitious plans.

But smaller biotech companies continued to stall research and development, hoping to create better treatments.

And now, their labor could be paying off.

That’s according to Laura Gault, the chief medical officer at Sage Therapeutics, a Massachusetts-based company that is working to develop a new antidepressant drug, called zuranolone. The company recently asked US regulators to approve the drug as a treatment for people with postpartum depression and major depressive disorder, citing data that the drug improved symptoms of those disorders in patients.

“Psychiatry is really on the verge of having novel medications that are really effective and work in different ways than what we’ve had,” Gault said.

Laura Gault, chief medical officer at Sage Therapeutics.

Laura Gault, chief medical officer at Sage Therapeutics.Sage Therapies

Gault said that as a result of the research done by mental health professionals in recent years, we now have a more sophisticated understanding of depression and other psychiatric disorders. These advances in science, she said, can now be translated into clinical trials.

“It’s very exciting to see and I’m very hopeful that we’ll see a resurgence of new approaches, new treatments and effective treatments for patients with psychiatric disease in the next five to 10 years,” she told Insider.

Sage is developing zuranolone through a partnership with biotech company Biogen. Last week, the companies announced that the Food and Drug Administration is set to decide whether to approve the treatment by August 5.

Sage stock has risen 7.9% over the past 12 months, giving the company a market value of about $2.7 billion.

Unlike most other antidepressants, zuranolone is designed to be taken for a short period of time.

In trials, zuranolone has improved symptoms of major depressive disorder and postpartum depression. The drug is designed to be an episodic treatment, meaning patients take the pill once a day for two weeks, and then stop.

Most antidepressants on the market today are thought to work by boosting the activity of neurotransmitters, or chemical signals in the brain that affect mood and emotions. Zuranolone works differently. Instead of affecting neurotransmitters, the drug affects the GABA-A receptor in the brain, which may play a role in depression.

Zuranolone has been tested over seven trials for major depressive disorder and postpartum depression. Although a late-stage trial to test the drug in MDD patients failed in 2019, a similar study in 2021, called WATERFALL, showed that the drug helped improve depression symptoms compared to a placebo.

If approved, zuranolone would enter a crowded market of generic antidepressants. Chris Benecchi, Sage’s chief business officer, said that despite the competition, he believes zuranolone will be an attractive option, especially for patients whose current treatment regimen is not working. About one-third of people who try antidepressant treatments do not get better.

“The sooner we can intervene and help a patient achieve response and remission, the better the long-term outcomes for that patient,” Benecchi said. He declined to say how much zuranolone will cost.

Episodic treatment could ‘make a huge difference to patients’ lives’

Sage Therapies

Sage Therapeutics is developing a new antidepressant that could be approved by the FDA as early as August.Sage Therapies

Some analysts noted that there are still open questions about how long the drug’s effects last and what dose of the drug might work best for patients.

William Blair analysts said in a February 6 note that the “marginal benefits” shown by zuranolone in trials could limit the drug’s appeal to patients, compared to existing treatments.

In a late-stage study, researchers tracked 489 patients – whose depression symptoms improved with zuranolone – for a year. They found that approximately a quarter of the patients required one additional course of treatment, and 30% required three or more courses.

The researchers used two common tests to determine if a participant was becoming depressed again and needed another course of treatment.

Sage said the median time patients underwent a relapse after their initial treatment was 135 days. Gault also said that for participants who received a higher dose of zuranolone, the median time to relapse increased to 249 days.

Gault said that a two-week treatment and having those effects last for months before receiving an additional course of therapy “makes a big difference in patients’ lives.”

Read the original article on Business Insider

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