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Anthera Pharmaceuticals Inc (NASDAQ:ANTH) Is A Discount Entry Opportunity

Anthera Pharmaceuticals Inc (NASDAQ:ANTH) Is A Discount Entry Opportunity
Written by
Chris Sandburg
Published on
January 16, 2017
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Anthera Pharmaceuticals Inc (NASDAQ:ANTH) plunged into the close of 2016, and hasn't been able to stage any degree of recovery throughout early 2017. The company fell foul of some negative data surrounding its lead asset in December, and sentiment reversed from what was essentially overwhelmingly positive to decidedly negative in a matter of hours. We think that there is the potential for a medium-term recovery, however, and in this recovery, there is an opportunity to pick up a discounted exposure to Anthera at its current capitalization. Here is a look at what underpins our thesis.In order to understand where we're going with this, it is first important to outline what just happened.The company is developing a cystic fibrosis drug called Sollpura. It's not a direct cystic fibrosis target, but instead it goes after one of the most common side effects/symptom conditions associated with CF; what's called exocrine pancreatic insufficiency. Cystic fibrosis sufferers have some pancreas issues, and this results in a range of complications. One of these complications is exocrine pancreatic insufficiency. The pancreas is responsible for producing digestive enzymes, which as their name suggests, are in turn responsible for breaking down the food we ingest through the process known as digestion. When the pancreas is not functioning properly, these digestive enzymes aren’t produced at a fast enough rate, and this results in the body not being able to digest food efficiently. When the inability to digest properly is rooted in a lack of properly functioning digestive enzymes, and when this lack of properly functioning digestive enzymes comes about as a result of cystic fibrosis induced pancreatic deficiency, it's called EPI.What's more important than the science right now, however, is the trial that just failed. The trial was split into two separate studies, both of which were phase 3s. One trialed a soluble form of Sollpura, and another trialed a pill form. The primary endpoints for both trials related to proving that Anthera's candidate was comparable in clinical benefit to the current standard of care. That's really important. It didn't need to prove that it was better, just as good. Why? Because the current standard of care has a range of drawbacks, not least of all that the dosing regimen is very intense (numerous pills daily) and that it is produced from pig enzymes, which brings up obvious religious issues.Sollpura is a once daily administration, and is human derived.Even with only having to show comparability, however, Sollpura failed against its primary endpoints. Normally, this would write a drug off, but in this instance, there are some mitigating factors. Primarily, that the trial design seems to have limited the drug's ability to perform in the active arm of the study. It didn't allow for dose expansion, whereas the control arm did, and Anthera's management believes that this differentiating factor is key to the disappointing performance.On the back of this interpretation of the results, Anthera is preparing a protocol for a fresh study, which it expects to kick off the early this year. This study will address the perceived limitations of the just completed studies, and – if Anthera is correct – should result in a comparability outcome that is far more favorable for Sollpura than the data we've already seen.In other words, the drug works, but the trial was set up wrong. When Anthera reinvestigates the drug with a revised trial protocol, we should see an endpoint hit. If we do, the company should quickly recover it lost value and more.There's risk, of course. A fresh phase 3 trial will cost money, and this is likely going to necessitate dilution. Additionally, the outcome may prove no different from the outcome we have already seen. From the available information, however, this doesn't look too much like standard biotechnology spin on the back of a failed trial. There is credence to the company's suggestion that the initial protocol was lacking, and – in turn – this paints Anthera as a potential discount entry.We will be updating our subscribers as soon as we know more. For the latest updates on ANTH, sign up below!Disclosure: We have no position in ANTH and have not been compensated for this article.

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