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George Ronan
George Ronan
Articles (67) 

Sage Therapeutics Wants to Show Its Treatment Can Help People Sleep

A look at what the company is trying to do with its lead development asset in sleep disorders

February 01, 2018 | About:

Sage Therapeutics Inc. (NASDAQ:SAGE) just announced it is going to try and show that one of its lead development assets, a drug called SAGE-217, can be used to help patients that suffer from certain types of sleep disorders.

Here's what this means for the company and the drug going forward.

Some readers may already be familiar with this asset. It is one that Sage has trialed in a number of different neurological-type indications over the past several years and it is one that, on the back of these trials, has shown some promise – especially in certain types of depression.

The drug is what is called a positive allosteric modulator. This class of drugs target synaptic and extrasynaptic GABA receptors, which are a class of receptors that respond to the neurotransmitter gamma-aminobutyric acid (where the GABA part of the name comes from), which is the chief inhibitory compound in the mature vertebrate central nervous system. These GABA receptors are essentially the opposite of the excitatory neurotransmitters that are responsible for stimulation in the brain. They down regulate stimulation and, by proxy, might be able to play a role in helping the parts of the brain that need to shut down do so when people want to go to sleep.

It seems like an oversimplified mechanism of action and, in concept, at least, it is.

That does not mean it is going to be a sure thing for Sage, however. Neurological conditions, especially conditions like sleep issues and insomnia, are tough to treat purely because we just do not know a whole lot about what causes them.

With that said, Sage would not be willing to spend the money on mid-stage clinical trials looking at SAGE-217 in this indication if the company did not believe it might have a chance of serving up some results that demonstrate clinical benefit.

So what gives the company confidence in this indication?

As mentioned above, the kicker for the advance into mid-stage trials is a phase Ib investigation that was completed earlier this year, which Sage reported data on Jan.31.

The data showed that, in 45 healthy patients, the drug resulted in improved sleep efficiency and demonstrated improvements in maintaining sleep compared to placebo. Further, it demonstrated clear dose response with statistical significance in total sleep time and time spent awake after sleep onset.

So that is a primary and a secondary endpoint hit, but here is the thing – the company only looked at 45 patients (as mentioned above) and the trial only lasted a little over two weeks. Not only, then, are we looking at a very small patient population (for a neurological condition, that is) but also a population that was healthy and only investigated over a very short period of time.

It is going to take advance on each of these fronts (so a longer trial in more patients and, indeed, patients that are suffering from sleep deprivation-related conditions) before Sage will have any data in hand that could even begin to underpin a registration application in the U.S.

So what's next?

The company has not put a specific date on the initiation of the trials, but has suggested it wants to kick them off at some point in 2018. There are not many companies investigating assets in this space, so there is a good chance Sage will pick up quite a lot of coverage as and when the trials begin.

None of this means anything, however, if the company fails to show SAGE-217 can be effective in this subpopulation.

Disclosure: The author has no positions in any of the stocks mentioned in this piece.

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