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Sage's new antidepressant is being called a "blockbuster" depression drug for good reason: It's the first federally-approved drug to significantly differ from nearly a half century's worth of antidepressants.
- On Monday, a new drug for depression got a big lift from positive clinical trial results.
- The drug is made by Sage Therapeutics, a Cambridge-based pharmaceutical company that focuses on brain disorders.
- Nearly all existing antidepressants, from Celexa to Zoloft, work on the brain's serotonin network. But the drugs fail for as many as 1 in 3 people and take 4-6 weeks to have an effect.
- Sage's new drug targets a different brain system than these antidepressants. As a result, it appears to work faster and last longer.
A drug that works differently than all existing antidepressants just got a big boost.
In results from its latest clinical trial on Monday, the drug, called Sage 217, appeared to relieve symptoms of post-partum depression in a sample of roughly 150 women. Made by pharmaceutical company Sage Therapeutics, the new drug candidate acts on the brain's gaba system, in stark contrast to all current medications for depression. Those drugs are called SSRIs (selective serotonin reuptake inhibitors) and effect the brain's serotonin network.
Some early research suggests it may even be possible for patients to go several weeks without taking the drug - as opposed to being tied to a daily pill. And analysts say the results suggest the drug would also be a good candidate for people with regular depression, also known as major depressive disorder, as well as those with post-partum depression or PPD.
Experts who study depression told Business Insider they'd been cheered by earlier study results on the drug, which suggested it could offer patients relief in a different way from current treatments.
The latest results bolster that analysis, they say, making the new drug potentially appealing for many patients.
However, although the drug appears to be a big innovation in several ways, those experts say it's worth noting that it would likely not work as a sort of one-and-done treatment in the way Sage CEO Jeff Jonas described over the summer.
Why Sage's new drug could be a game changer for people with depression
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Sage-217 may not require patients to take the drug daily as they would with current antidepressants.
For its latest study, researchers concluded that Sage-217 worked fast and well, noting that most patients observed a relief in symptoms as early as three days into the treatment. Those results were maintained for at least a month.
"In our view, these data not only provide a more commercially viable product for post-partum depression, but should also further increase investor confidence in the ongoing Phase 3 trial in the broader population of patients [with major depression]," JPMorgan analyst Cory Kasimov wrote in a note
A drug that works fast and lasts is something that most patients with depression have never seen. For all of the hope that drugs like Celexa and Prozac have inspired, they don't work for as many as one in every three patients.
In addition, the drugs - which target the brain's serotonin system and are thus known as SSRIs (selective serotonin reuptake inhibitors) - take roughly 4-6 weeks to work.
That's not quick enough for patients with severe depression and suicidal thoughts, according to Cristina Cusin, a psychiatrist at Massachusetts General Hospital and an assistant professor at Harvard University who specializes in severe depression.
By contrast, Sage's drug appears to take an effect as quickly as two weeks into treatment - not as fast as rapid-fire anesthetic drug ketamine, but significantly quicker than all existing approved antidepressants.
Wall Street analysts say they see a huge market potential for the new drug.
Latest results are 'a best case scenario' for the new drug
The results the company released this morning "represent essentially a best case scenario," for the drug, wrote JPMorgans' Kasimov.
Others agreed.
"The possibility of having something that impacts the Gaba system is attractive because if you were to launch it tomorrow, there's likely going to be lots of patients who've failed with anything that's available," Paul Matteis, the managing director of biotech research with brokerage firm Stifel, told Business Insider in December.
Plus, the drug may not require patients to take it daily, at least according to both the latest study and a series of preliminary results from the company's clinical trials.
That's something that Matteis said sounds like it would be "preferred by most patients than having to take something indefinitely."
That optimism is what Sage CEO Jonas was likely alluding to when he made his comments about Sage-217 over the summer, Matteis said.
In June, Jonas said Sage-217 had the potential for patients with depression "to feel well within days, with just a two week course of treatment - similar to how antibiotics are used today."
Shortly after he made that statement, the company's stock surged.
Yet instead of taking the drug only once, most experts say patients would likely need to take it "episodically" - meaning as frequently as once a month. That's still a big change from the way current antidepressants are administered, and could be a significant boost for patients, said Matteis.
"Any paradigm-shifting drug is going to have some nuances that, I don't wanna say are scary, but are counterintuitive to the current therapy model."