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Anthera Pharmaceuticals Inc (NASDAQ:ANTH) Just Jumped: What's Next?

Anthera Pharmaceuticals Inc (NASDAQ:ANTH) Just Jumped: What's Next?
Written by
Chris Sandburg
Published on
June 15, 2017
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In mid May, a week or so after the company had carried out a reverse split, we highlighted Anthera Pharmaceuticals Inc (NASDAQ:ANTH) as potentially being worth a punt. The company was – at that time – about to kick off a phase III trial of its lead development asset, a cystic fibrosis (CF) drug called Sollpura, and we put forward a couple of catalysts that we had slated as potentially injecting some upside momentum into its valuation.At that time, Anthera went for around $1.65 a share. In the weeks subsequent to our coverage it traded relatively flat, until yesterday. From a $1.62 open on Tuesday the company ran up to a $1.95 close, and then to $2.08 early session on Wednesday.We think this action comes as markets load up ahead of a potential revaluation, in response to the company confirming a trial design that we highlighted as essential to its success in the ongoing pivotal and – at the same time – played a key role in the relative failure of the late-stage studies that fed into the above noted pivotal.So, with this confirmation in place, and with markets finally looking to be taking notice to this potential undervaluation, here’s what we’re looking for next as confirmative of or expectations.For those new to this, Sollpura is basically a synthetic version of an already widely used treatment in the CF space that goes after what’s called exocrine pancreatic insufficiency (EPI). When the pancreas doesn’t work as it should (as is often the case in CF patients), not enough digestive enzymes are produced. A lack of digestive enzymes results in a patient having trouble digesting food and this is the EPI that the drug is targeting.Current SOC has an intense dosing regimen (numerous pills daily) and that it is produced from pig enzymes, which brings up obvious religious issues. In contrast, Sollpura is a once daily administration and is human derived.The drug tripped up in two phase III trials that attempted to show comparability between Sollpura and SOC. At the time, we put forward the suggestion that it failed because it didn’t allow for dose expansion in the active arm and that, if the company could amend this and carry out a fresh trial with dose expansion a possibility, it could turn the failure into a success.And what did we see next?The company kicked off a trial that allowed for dose expansion in the active arm. The first screening came mid-May and the trial is once again a non-inferiority study. All Anthera has to do is show that Sollpura can match the clinical benefit of SOC, and with a variety of doses now on offer, there’s a very good chance it’s going to be able to do just that.Data from this study is going to be available by the end of 2017 (optimistic) or early 2018 (conservative). If the numbers hit press as supportive of the above outlined non-inferiority endpoint the company is going to take off.Cash at the end of the first quarter came in at $20.7 million, which based on a burn of a little over $10 million during the first quarter (and factoring in that a phase III trial is underway) should carry it through to fourth quarter this year. That, for us, is the primary risk right now. We want to see the company get as close to topline as possible before raising, so as to limit the potentially dilutive impact of any such raise on the holdings of shareholders that sought to pick up an exposure to the catalyst.All said, this one remains a bit of a punt, but it’s got a real chance of success in a pivotal phase III and a catalyst for the end of the year, to which cash on hand should just about carry through.Readers looking to get up to date with this one should check out our previous coverage of ANTH here.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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