Esperion (NASDAQ:ESPR) was one of the midweek movers in the biotechnology space this week, with the company putting out data related to one of its lead investigative assets and picking up some considerable volatility on the back of the release.
For those not familiar with Esperion, the company is trying to develop a drug called bempedoic acid, which it is attempting to show can be a safe and effective treatment in patients with hypercholesterolemia. Hypercholesterolemia is basically just a fancy word for high cholesterol, which, in turn, is the presence of high levels of cholesterol in the blood. Elevated blood lipids can lead to a whole host of different complications, perhaps the most well-known of which is heart failure but also the list includes the failure of numerous other organs, as well as some general quality of life-related complications.
As far as the mechanism of action (MOA) is concerned, bempedoic acid inhibits cholesterol synthesis and upregulates LDL receptors on liver cells and, at the same time, lowers LDL-C (which is the bad cholesterol associated with the above-discussed complications).
This is a similar mechanism to that of one of the current leading standard of care treatments in the space, statins, but unlike statins, bempedoic acid does not inhibit the cholesterol biosynthesis pathway in skeletal muscle, nor does it promote the associated cytotoxicity that is believed to lead to muscle-related side effects.
So, with this latest trial, the idea was to show that this drug can not only work effectively towards its target aim of reducing levels of cholesterol in patients but also that it could establish a benefit over current standard of care.
And as per the release, things look pretty good.
The data showed an additional LDL-C lowering of 30% (p<0.001). Further, the LDL-C lowering for the bempedoic acid group was 27% from baseline, as compares to an increase of 3% for the placebo group.
This means that the trial met its primary endpoint (it’s a phase 2 trial) and that the drug can march towards a registration trial later this year.
There is also some data set for release in May, as relates to the same asset, so markets will be looking at this trial data carefully to gain insight into whether this drug can perform consistently in its target patient populations or not.
As mentioned above, the action we saw on the back of this development was pretty volatile, with the company gaining 10% initially (immediately subsequent to the release) but returning to trade relatively flat on its preannouncement pricing heading into the daily close on Tuesday.
Chances are we will see a continuation of this volatility moving into the May scheduled data release.
Another mover during the middle of this week was Altimmune, Inc. (NASDAQ:ALT).
Altimmune just put out data from a phase 2 trial of its NasoVAX asset, an intranasal influenza vaccine and, at the same time, data from its Phase 1b trial of HepTcell, which is currently under investigation as a potential treatment for chronic hepatitis B infection.
As per the release, the influenza vaccine data came back pretty positive, with the company reporting a 100% seroprotection rate in the mid- and high-dose groups, compared with 95% for Fluzone, a licensed injectable influenza vaccine.
At the same time, however, the phase 1 data, the hepatitis data, disappointed, and it seems to be this side of the release that’s dominating sentiment. As per the release, HepTCell unblinded T-cell immunogenicity results were inconclusive, meaning that, at this stage, essentially, the trial can be deemed to have failed.
The company says that it is still looking at the results, suggesting that there may be some degree of insight on offer between now and markets receiving the final word on this trial, but as things stand, it doesn’t bode well to see inconclusive numbers on the back of such an early stage study.
As mentioned, markets seem to be favoring the earlier stage trial as far as impact on capitalization is concerned and Altimmune closed down on its preannouncement opening price to the tune of 18% on Tuesday.
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