Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) Is Gearing Up For Interim HCV Release Next Month

Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) just reported that it is set to release its latest data from a lead HCV combo trial at the European Association for the Study of the Liver (EASL) Special Conference in September. The trial is a real hot focus in the space right now, with the company’s triple regimen therapy being touted as the next big step in once daily oral maintenance in the condition. We’ve got about a month before the data hits, and chances are we will see plenty of speculative volume ahead of the release. With this in mind, and as we head into the closing month of the quarter, here’s a look at the drug/s in question, and what to keep an eye out for when the data hits press.

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So, the drugs. Achillion has developed a triple regimen of three different HPV compounds, odalasvir, AL-335 and simeprevir. The first of these is a compound that Achillion has developed, while the other two are compounds developed by Johnson & Johnson (NYSE:JNJ)’s Janssen subsidiary. Simeprevir is already approved and branded as Olysio, while AL-335 is still investigational. All three of the compounds inhibit a different protease – with each protease being responsible for a different element of viral replication in HCV. The three protease targets are NS5A, NS3, and NS5B. Olysio has already been demonstrated to be effective in this indication. The hope is, however, that by combining the three compounds and administering them as a triple regimen, the treatment can produce what is called a sustained virologic response when taken once daily orally across a comparatively short dosage timeframe (in this instance, around 12 weeks). This short dosing twelve-week regimen is something of a holy grail in HCV treatment, and if these two can get the treatment to market, it could be a real breakthrough for both as far as bringing a first in class candidate to commercialization is concerned.

The World Health Organization estimates that around 4% of the global population has HCV – somewhere in the region of 170 million individuals. In the US, estimates put this number  at around 4 million individuals. There are six different genotypes, and this has proved problematic by way of making it difficult to standardize a therapy in a population. At the moment, big Pharma Gilead Sciences, Inc. (NASDAQ:GILD) dominates the space, but if Achillion and Janssen can get this triple regimen approved, it would be able to target multiple genotypes, and as such, could pick up a decent share of the market from Gilead.

So, what are we looking for in the upcoming data?

Well, the trial is split into four different groups, two of which will receive all three drugs, one for six weeks and one for eight weeks, and the other two of which will receive just AL-335 and odalasvir, again, one group for six weeks and one group for eight weeks. The primary endpoint is the percentage of chronic HCV infected subjects who achieve sustained virologic response 12 weeks after the end of treatment, with this response defined as hepatitis C virus (HCV) ribonucleic acid (RNA)<lower limit of quantification (LLOQ =15 IU/mL, detectable or undetectable). This is a pretty standard definition, and we want to see a good portion of patients hit it to consider the endpoint as hit when topline comes out. From this interim data, we will probably see data that relates to SVR at dose completion, since the trial only kicked off a couple months ago. This doesn’t mean we won’t get any insight into efficacy, however. Specifically, we’re looking for a sustained virological response in as many patients as possible, interim. We would consider anything above 50% as statistically significant, and we would also like to see an improvement in the numbers between the two drug regimens and the three drug regimen, as this would support Achilion’s hypothesis.

When should we be watching for the presentation?

The company is set to report the data at the above mentioned conference at the end of September, with September 23 touted as the day to keep an eye on.

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