Upcoming Phase IIa trials results make Achillion worth watching Print E-mail
By Brian Wilson, Contributor   
Tuesday, 03 April 2012 04:07
Achillion Pharmaceuticals (ACHN) is a development-stage pharmaceutical company developing treatments that combat the heptatitis C virus, which is estimated by the company’s website to affect over 170 million worldwide.

If pharmas want to sell into emerging markets they will need a product list that includes HCV drugs, Behzad Aghazadeh of venBio told BioCentury this week.

“They have to sell into China with a full package — cardiovascular, diabetes, vaccine, hepatitis B and C,” Aghazadeh said. “If they don’t have it that weakens the portfolio selling opportunity; that’s how you sell into China as opposed to in the U.S., where they are selling to individual doctors.” Aghazadeh sees GlaxoSmithKline plc and AstraZeneca plc as among potential acquirers of HCV companies. According to the "2Q Financial Markets Preview" published for BioCentury subscribers, Idenix Pharmaceuticals Inc. and Achillion Pharmaceuticals Inc. are names several buysiders said they have a position in or are watching closely. Each will present at the European Association for the Study of the Liver (EASL) meeting in Barcelona on April 18-22. Abstracts will be available starting on April 4.

Achillion's pipeline also includes one preclinical-stage drug being developed for bacterial infections, although the bulk of the company’s resources are being spent on HCV (heptatitis C virus). Achillion have five separate HCV drugs in various stages of development, most notable is ACH-1625 which is classified as a protease inhibitor.

The hepatitis C virus, in order to replicate, needs particular protease enzymes to construct new virions which allow the disease to continue to attack the body. ACH-1625 is an inhibitor of the HCV NS3 protease, which means this drug should prove effective if it can prevent this protein from functioning. The NS3 protein that is targeted by ACH-1625 has been studied extensively, and serves critical functions in the HCV infection process. All non-structural proteins with regards to HCV are processed by NS2 and NS3, and due to their necessary interaction, inhibition of NS3 should hypothetically be a nearly-insurmountable obstacle for HCV replication. As of now, ACH-1625 has passed Phase I trials which have validated its relative safety and lack of side-effects. Phase II trials will give further insight into the efficacy of the drug against viral replication by HCV.

ACH-2684 is a broader protease inhibitor being developed to suppress the natural variants of the hepatitis C virus by the same mechanism. According to the company, the compound is also potent against standard genotypes of HCV which means it could be just as (if not more) effective than inhibition of just the NS3 protein, although the company claims that it has actually been tailored to affect the NS3 protease. The efficacy of this broader ranged protease inhibitor is difficult to determine at this stage, since it has only proven potency in the “low pico-molar range” (an incredibly small volume), but the fact that it might target mutant strands of HCV makes it worthwhile.

The third drug in the pipeline that has begun its clinical trials is ACH-2928, which acts through another mechanism by inhibiting HCV NS5A. This protein actively antagonizes a cell’s response to a viral infection through RNA-binding, and research is being done to investigate its suspected role in genome replication. The second generation version of this, ACH-3102, is being developed with enhanced abilities to fight off resilient strains of HCV that would be less susceptible to ACH-2928.

ACH-1625 will be releasing results of its Phase IIa clinical trials on April 18-22, at the International Liver Conference being hosted in Barcelona.  Shares have already rocketed up at the start of 2012, but there’s reason to believe that some early confirmation of ACH-1625’s efficacy in a larger sample size could be immensely beneficial for the stock. News may be slow after this since many fresh studies are being started this year, but investors may jump the gun if the data on this generation of protease inhibitors gives hope on stopping HCV.

That being said, from a purely technical perspective (see chart) , the market could be hinting that a move like we saw earlier in the year might occur when details of those results come.

Disclosure: None

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