Hepatitis C, one of the major causes of liver failure, is caused by hepatitis C virus, which is spread from person to person through contact with infected blood. It is estimated that about 3.2 million Americans, and 170 million people worldwide, are chronically infected with hepatitis C virus, or HCV for short.
The standard treatment for hepatitis C is a 48-week treatment of pegylated interferon and ribavirin. Given the fact that the current standard-of-care therapy is associated with poor response rates and significant side effects, novel medicines which could change the hepatitis C treatment landscape are being explored. Hepatitis C is a lucrative market, and analysts estimate the total sales of hepatitis C drugs to reach $10 billion by 2017.
Building a pipeline of drug candidates for HCV, in addition to antibacterial drug candidates for the treatment of serious, resistant bacterial infections, is Achillion Pharmaceuticals Inc. (ACHN). For readers who are new to Achillion, here's what to expect in the coming months...
The company has three clinical candidates for the treatment of chronic hepatitis C infection - ACH-1625, a proprietary potent, once-daily NS3 protease inhibitor currently in phase II clinical development; ACH-2684, a pan-genotypic inhibitor of HCV NS3 protease in phase I development and ACH-2928, a pico-molar potent inhibitor of HCV NS5A , also under phase I development. The company also has several additional NS5A inhibitors currently in preclinical development.
The NS3 and NS5A are viral proteins which play a critical role in the replication of HCV. Achillion's HCV therapies are inhibitors of these viral proteins, which are designed to disrupt the active viral RNA replication.
Achillion initiated the phase II study of ACH-1625 in September 2010 in genotype 1 treatment naive HCV-infected patients. The study has two segments -segment 1 evaluating the safety, tolerability and antiviral activity of once daily ACH-1625 in combination with standard of care after 28 days of dosing, and segment 2, which evaluates the safety, tolerability and antiviral activity of once daily ACH-1625 in combination with standard of care after 12 weeks of dosing.
In March of this year, the company reported top-line results from the first segment of the phase II ACH-1625 study, demonstrating that patients treated with ACH-1625 in combination with standard of care achieved a rapid viral response of 75 percent to 81 percent compared to 20 percent for patients receiving standard of care alone.
The company will be reporting updated results from the first segment of the phase II ACH-1625 study on November 7 at the 62nd Annual Meeting of the American Association for the Study of Liver Disease in San Francisco, California.
The second segment of the phase II ACH-1625 study was initiated in June of this year and the 12-week complete early virologic response results are scheduled to be announced this quarter (4Q).
There continues to be a significant unmet need in the hepatitis C arena, given the limited efficacy in some population and safety profile of the current standard treatment for HCV. According to Achillion, ACH-1625 has the potential to offer convenient once-daily dosing and an improved safety and tolerability profile compared with other protease inhibitors being studied for the treatment of hepatitis C.
The phase I trial of ACH-2684 for the treatment of hepatitis C was initiated in May of this year and the phase I trial of ACH-2928, also for the treatment of hepatitis C, was commenced in July, 2011.
The ACH-2684 study consists of three segments, including assessment of single ascending oral doses in healthy volunteers, a 14 day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with either genotype 1 or genotype 3 hepatitis C infection.
The ACH-2928 study consists of three segments, including assessment of single ascending oral doses in healthy volunteers, a 5-day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with genotype 1 hepatitis C infection.
The proof-of-concept phase 1 results for both ACH-2684 and ACH-2928 are expected to be reported by the end of this year.
Achillion expects to initiate during 2012 a clinical trial evaluating ACH-1625 in combination with ACH-2928.
Elvucitabine is another compound in Achillion's pipeline - a phase II product candidate for the treatment of both hepatitis B virus infection and HIV (human immunodeficiency virus) infection. Last February, Achillion signed a license agreement with New Jersey-based GCA Therapeutics, Ltd. for the development and commercialization of Elvucitabine in mainland China, Hong Kong and Taiwan.
Achillion's preclinical pipeline includes ACH-1095, a NS4A antagonist for the treatment of chronic hepatitis C, ACH-702 and ACH-2881 for the treatment of serious bacterial infections.
Gilead Sciences Inc. (GILD) retains certain future development rights of ACH-1095, and Achillion is seeking appropriate collaborative partners for the other preclinical compounds.
However, for the time being, the company has no plans to clinically advance Elvucitabine or its antibacterial drug candidates, ACH-702 and ACH-2881, independently.
A quick look at the company's balance sheet...
Achillion has no marketed drugs. Since inception in August 1998 through June 30, 2011, the company had incurred a loss of $239 million. To date, the majority of revenue recognized has been derived from the collaboration with Gilead to develop compounds for use in treating chronic hepatitis C.
In the second quarter of 2011, Achillion incurred a net loss of $11.25 million or $0.19 per share, wider than $6.32 million or $0.17 per share in the comparable year-ago quarter. Revenue recognized in the second quarter of 2011 declined to $56,000 from $187,000 reported in the second quarter of 2010. The decrease in revenue in 2011 is primarily related to the recognition of Small Business Innovation Research grant revenue during 2010.
Achillion went public in October 2006, offering its shares at $11.50 each. Over the last twelve months, ACHN has traded in the range of $2.60 to $8.95. Yesterday, the stock closed up 8.96% at $4.50.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.