We are closing in on the end of another week in the biotechnology space and as readers who have caught our analysis throughout the week so far will know, it’s been a pretty busy one.
Things aren’t going to slow down just because it’s Friday, however.
We have a number of fresh inputs to discuss today, some of which are long-awaited developments for the companies to which they relate.
So, here goes.
The two companies we are focusing on for the session today are Sage Therapeutics (NASDAQ:SAGE) and Dynavax Technologies Corporation (NASDAQ:DVAX).
First up, then, Sage.
On Thursday, Sage announced some data from a couple of phase 3 trials that were set up to investigate the safety and efficacy of a drug called brexanolone. This is one of the company’s lead development assets and it is one that markets have been keeping a close eye on as potentially being a real revenue generator for Sage if and when it hits markets in the US.
The drug is what is called an endogenous inhibitory pregnane neurosteroid and it is synthesized from progesterone. The science behind this mechanism of action is pretty complicated but it can be simplified by saying that it has a similar action to positive allosteric modulators of the GABA action at GABAA receptor – things like benzodiazepine. Basically, it induces antianxiety, sedation and anticonvulsant activity in the patients that take it.
The idea of these trials was to show that it could be useful in moderate and severe postpartum depression (PPD), which is the depression new mothers suffer from immediately after giving birth, usually lasting for around six months.
The primary endpoint of the study was a mean reduction in severe depression and, as per the latest data, the drug hit on this goal. As compared to a score of 14.0 for placebo, the drug brought about a mean reduction in severe depression of 17.7 points in a low-dose trial and these two numbers change to 14.0 (placebo) and 19.9 (for active drug) respectively for the second of the two phase 3 trials, which looked at the drug in a high dose setting.
Not only have we got positive results in terms of efficacy implications here, therefore, but we’ve also seen the drug demonstrate a dose correlation effect, which is a strong kicker for a trial like this.
The company hasn’t served up any specifics as to when it intends to push forward and use this data to underpin a registration application but there is a good chance we will see said submission at some point during the first quarter of next year at the outside.
Next up, Dynavax.
For nearly half a decade, Dynavax has been trying to get a drug called Heplisav B to market in the US. It is a hepatitis B vaccine that builds on the current standard of care vaccines in this space by allowing for a two-dose administration regimen as opposed to the current three-dose regimen necessity. This doesn’t seem like a massive change, but when you consider that these doses need to be spread out over six months (for the current three dose standard of care) and that up to 50% of people who take the first and second doses don’t complete treatment by taking the third (and, by proxy, don’t develop full seroprotection, the advantages of a reduction to a two dose regimen become clear.
So why did Dynavax make the list today?
Because, as of yesterday, the FDA in the US has approved the drug in its target indication of vaccination against hepatitis B in a broad population of patients.
This is a major development for Dynavax and it comes after repeated setbacks (the latest of which came as recently as August this year), allowing the company to draw a line under what has been an expensive (both in terms of time and money) program.
The announcement came after hours on Thursday so the full impact of the development is not yet being felt in the markets. However, after hours, the company ran to the tune of 16% and looks certain to continue to appreciate as markets open for regular participation on Friday morning.
At the open today, Dynavax shares will trade for a little over $23.10 a share.