SAGE Therapeutics Inc (NASDAQ:SAGE) is running up on a trial update this week, with the company currently trading a little over 12% higher than its close on Friday. The gains relate specifically to an accelerated development plan now in place for its lead postpartum depression (PPT) asset, and are likely to continue as markets take stock of what the development in question means for both the development pathway of the drug, and its chances of commercialization.
Here’s what you need to know.
So, the data relates to the above-mentioned PPT asset, a drug called SAGE-547. The drug is what’s called an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. Receptors have ligands, and the ligand associated with these receptors is a neurotransmitter called – not surprisingly – aminobutyric acid (GABA). Basically, GABA binds to the GABAA receptors, and this causes a variety of neurological responses. Through the modulation of these receptors, therefore, SAGE is hoping it can – in turn – modulate the causes of this type of depression.
As a quick note, for those not familiar with this condition, it the depression that affects new mothers immediately (or a matter of months) after childbirth. It’s been known to affect men as well, but the target for 547 right now is going to be women. The condition affects as many as one in eight new mothers, making it extremely common and – by proxy – a huge potential market for Sage if it can get 547 through to market by way of a successful registration.
So, what’s the news?
Well, the drug is currently under investigation as part of a phase II trial. The company initially thought (as did shareholders) that the next step would be a pivotal trial initiation, with the standard protocol changes – greatly improved sample size, extended follow ups, etc. However, after a meeting with the FDA, Sage has been able to put together (and more importantly, get approved for) an accelerated development plan. These sorts of plans are designed to bring much-needed drugs to market quicker than might otherwise be possible under standard development protocol, and their implications vary from one case to another.
In this instance, the plan means that Sage isn’t going to have to conduct a phase III trial (at least, that is, not a separate one) and that instead it can just alter the current phase II protocol and use the alterations as forming the basis of a registration trial. There are a couple of small changes needed, with the major one (and we say major, it’s not major, but it’s the most prominent of the bunch) being a slight increase in sample size.
So what’s next?
The phase II is ongoing, and the protocol alterations are going to add a little bit of extra time on to the target completion date, but shouldn’t be too impactful. SAGE Therapeutics Inc (NASDAQ:SAGE) has stated in the past that it expected to put out top-line data from the phase II trial (in its previous form) either late in the first-half of 2017, or early in the second-half. It now looks as though this is going to expand to the second-half of the year (based on the company’s addressing the changes in market releases) but still, there’s not far to go before we get an insight into the drug’s impact in this population.
If the data comes out as indicative of efficacy, and assuming it maintains a relatively clean safety profile (which, in the past, it has managed to do) then Sage is looking at a New Drug Application (NDA) submission during 2018. We don’t have any more specific dates than the 2018 bracket, but we’re willing to take a leap of faith and say that the first-half of 2018 is reasonable. These aren’t massive trials, and the company should be able to aggregate the data and get it in submission form relatively quickly.
There’s also a chance we might see some interim early-2017 data, based on the initial (i.e. pre-expansion) population. If this turns out to be the case, then we’ll get some insight into the chances of approval come the 2018 submission, and the release could be a major catalyst for the company near term.
We’re watching this one closely as things develop. With a couple of potential major near term catalysts, and some solid assets a little farther down its pipeline, SAGE Therapeutics Inc (NASDAQ:SAGE) is worth keeping an eye on as its situation matures.
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Note: This article is written by Mark Collins and was originally published at Market Exclusive.