Achillion Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes treatments for infectious diseases. Within the anti-infective market, the company is focusing its efforts on developing commercially competitive, short-duration combination therapies for the treatment of chronic hepatitis C (HCV) infection that are administered once-daily, orally, and without ribavirin. Primarily, the company is advancing ACH-3102, a NS5A inhibitor, in phase II clinical development, and the cornerstone of its genotype 1b strategy; ACH-3422, a NS5B nucleotide polymerase inhibitor, being prepared for phase I clinical development, and the cornerstone of it genotypic strategy; and ACH-2684, a NS3/4A protease inhibitor, being prepared for phase II clinical development. In addition to the company’s HCV drug candidates, it has established a pipeline of certain antibacterial product candidates for which the company has sought appropriate collaborative partners. The company has also developed and out licensed certain development and commercialization rights to elvucitabine, for the treatment of both hepatitis B, or HBV, and human immunodeficiency virus, or HIV. Drug Candidates ACH-3102, a NS5A Inhibitor The company is developing a combination drug regimen to address HCV genotype 1b, the prevalent genotype of HCV in the world, based on use of ACH-3102, its pan-genotypic, second generation NS5A inhibitor, with one of its protease inhibitors. As of December 31, 2013, the company had completed two phase II 12-week clinical trials with ACH-3102, including the -007 trial with sovaprevir, which examined the use of ACH-3102 in combination with sovaprevir and ribavirin; and the -005 study, which examined the use of ACH-3102 with ribavirin alone. ACH-3422, a NS5B Nucleotide Polymerase Inhibitor The company is developing a regimen to address all HCV genotypes based on use of ACH-3422, its nucleotide prodrug inhibitor of HCV NS5B polymerase in combination with ACH-3102, its NS5A inhibitor, and with a NS3/4A protease inhibitor. The company has completed a 28-day safety study in animals. The company intends to initiate a phase I first-in-human clinical trial outside the United States with ACH-3422 in 2014. It intends to initiate a clinical trial based on ACH-3422 in combination with other agents by the end of 2014 and in combination with other of its direct acting anti-virals, or DAAs, in 2015. ACH-2684, a NS3/4A Protease Inhibitor ACH-2684 has completed phase Ib proof-of-concept clinical studies, including three segments, such as once-daily dosing in genotype 1, twice-daily dosing in patients with genotype 3, and once-daily dosing in patients with cirrhosis. Cirrhosis is an abnormal liver condition characterized by irreversible scarring of the liver. Once-daily doses of 400mg of ACH-2684 reduced viral load by a mean maximum 3.73 log10 in genotype 1 HCV patients. In addition, twice daily doses of 400mg of ACH-2684 reduced viral load by a maximal 2.03 log10 in patients with HCV genotype 3. Lastly, once-daily doses of 400mg administered for three days to HCV patients with cirrhosis achieved a mean maximum 3.67 log10 reduction in HCV viral load, similar to the antiviral activity achieved in non-cirrhotic genotype 1 HCV patients receiving the same dose of ACH-2684. ACH-2684 demonstrated good safety and tolerability in these phase Ib clinical studies, as well as in phase Ia studies in healthy volunteers. Development of ACH-2684 is included in both parts of the company’s business strategy, first, with ACH-3102 as part of its genotype 1b strategy, and second, with ACH-3422 and ACH-3102 as part of its genotypic development strategy. Sovaprevir, a NS3/4A Protease Inhibitor The company completed a randomized, double-blind phase II clinical trial that evaluated 12 weeks of treatment consisting of sovaprevir and its NS5A inhibitor, ACH-3102, with ribavirin for the treatment of genotype 1 HCV (the -007 trial). In 2013, the U.S. Food and Drug Administration (FDA) placed a clinical hold on sovaprevir after elevations in liver enzymes were noted in a phase I healthy subject drug-drug interaction study evaluatin
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