NEW HAVEN, Conn., June 9, 2008 (PRIME NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (NasdaqGM:ACHN - News), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced additional positive safety and efficacy results from its ongoing Phase 2 trial studying elvucitabine in patients infected with Human Immunodeficiency Virus (HIV). Elvucitabine, Achillion’s HIV product candidate, is an L-cytosine nucleoside analog reverse transcriptase inhibitor (NRTI) that has previously demonstrated potent antiviral activity against HIV, including strains resistant to other NRTIs.
48-Week Safety and Efficacy Findings
The objectives of the trial, ACH443-015, include the assessment of safety, tolerability and antiviral activity with a once daily 10 mg dose of elvucitabine, as compared to 3TC (lamivudine), in a standard triple-combination regimen. The results at 48 weeks demonstrated that elvucitabine had a substantial anti-viral effect similar to 3TC, with a mean change in HIV-RNA from base-line in the elvucitabine treatment group of -3.0 log10 (+/-0.55) vs. -3.2 log10 (+/- 0.6) in the 3TC treatment group in the as-treated patient analysis. In the elvucitabine-treated group, 96% of patients reached undetectable viral load, defined as achieving fewer than 50 copies/ml after 48 weeks of therapy, compared to 97% in the 3TC group. Elvucitabine was well-tolerated and demonstrated a safety profile comparable to 3TC for both incidence and severity of adverse events. Additional results from this trial at 96 weeks will be announced once available. Full data on interim results will be presented at the XVII International AIDS Conference in Mexico City on August 5, 2008.
``Elvucitabine continues to demonstrate substantial antiviral activity with a generally safe and tolerable side effect profile. Importantly, these data show that elvucitabine has a durable response, with 96% of patients achieving undetectable viral loads at 48 weeks,’' said Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer. ``We are encouraged that, as these data mature, elvucitabine continues to demonstrate excellent safety and efficacy, while offering an important potential treatment option for HIV patients.’'
``These 48 week data confirm our belief that elvucitabine offers a very promising treatment for use in combination therapy, and we are pleased to see that the response to elvucitabine is sustained over time, ''commented Michael D. Kishbauch, President and CEO of Achillion. ``We look forward to reporting final data from these cohorts.’'
Study Design
ACH443-015 is a randomized, double-blind study in patients infected with wild-type HIV-1 virus. The trial included a 12-week blinded treatment period after which responders (patients with viral loads below 400 copies/ml, or less than 2 log10 decrease) continued to a now ongoing 84-week open-label extension period. The trial enrolled 78 subjects who were randomized 1:1 into two treatment groups: 10 mg/day elvucitabine with 600 mg/day efavirenz and 300 mg/day tenofovir or 300 mg/day 3TC with 600 mg/day efavirenz and 300 mg/day tenofovir.
About Elvucitabine
Elvucitabine, Achillion’s HIV product candidate, is an L-cytosine nucleoside analog reverse transcriptase inhibitor (NRTI) that has demonstrated potent antiviral activity against HIV, including strains resistant to other NRTIs. NRTIs are the predominant class of drugs for use in HIV combination therapy and are frequently prescribed given their established potency, favorable short and long-term safety profile and fewer and less severe adverse side effects. Clinical and pre-clinical data collected to date indicate that elvucitabine can be dosed as a 10 mg pill once daily and may be used in combination therapy. In addition, the L-nucleoside configuration of the compound may provide protection against mitochondrial toxicity, a serious side effect often seen with D-nucleosides. Finally, elvucitabine has been demonstrated to have a longer half-life than other approved NRTIs, providing a potential barrier to the emergence of drug resistance in patients who are less than perfectly compliant.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The company’s proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- HIV, hepatitis and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit the company’s web site at http://www.achillion.com or call Achillion at 1-203-624-7000.
ACHN-G
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to Achillion’s expectations regarding the timing and duration of clinical trials and the Company’s expectations regarding the release of data from ongoing clinical trials. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected regulatory actions or delays; uncertainties relating to results of clinical trials, including additional data relating to ongoing clinical trials and Achillion’s ability to obtain additional funding required to conduct its research, development and commercialization activities along with Achillion’s ability to attract and develop potential collaboration relationships. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the three months ended March 31, 2008. All forward-looking statements reflect Achillion’s expectations only as of the date of this release and should not be relied upon as reflecting Achillion’s views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Contact:
Achillion Pharmaceuticals, Inc. Mary Kay Fenton (203) 624-7000
MacDougall Biomedical Communications, Inc. Media: Kari Watson (781) 235-3060
Source: Achillion Pharmaceuticals, Inc
