Achillion Reports Safety and Potent Antiviral Activity in Topline Results From Elvucitabine Phase 2 Study in HIV-Infected Patients
NEW HAVEN, Conn., Oct 15, 2007 (PrimeNewswire via COMTEX News Network) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced preliminary 12-week results from an ongoing Phase 2 clinical trial studying elvucitabine in patients infected with wild-type Human Immunodeficiency Virus (HIV). Elvucitabine, Achillion's lead 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.
The objectives of this study include demonstration of the safety, tolerability and antiviral activity with a 10 mg dose of elvucitabine, as compared to 3TC (lamivudine) in a standard triple-combination regimen. The results at 12 weeks demonstrated potent anti-viral activity similar to 3TC, with a mean change in HIV-RNA from base-line in the elvucitabine group of -2.7 log10 (+/-0.82) vs. -3.0 log10 (+/-0.79) in the 3TC group. In addition, elvucitabine was well-tolerated, with no serious drug-related adverse events. Full results from this trial, along with data extending to 24-weeks, will be presented at a future scientific forum.
"We are extremely pleased that these preliminary results support the use of elvucitabine as part of a triple-drug combination," said Milind S. Deshpande, Ph.D., Executive Vice President of Research and Chief Scientific Officer. "The results from this trial are an important positive step in validating the safety and efficacy of elvucitabine in a 10 mg daily dose. Taken together with its demonstrated long half-life, and its favorable resistance profile, elvucitabine is emerging as a potentially important alternative to currently available nucleosides in the treatment of HIV patients."
"As we anticipated, the end of 2007 is going to be an important period for Achillion, as we prepare to report additional data from our Phase 2 program with elvucitabine," commented Michael D. Kishbauch, President and CEO of Achillion. "The majority of the patients in this ongoing study have already completed 24-weeks of treatment, and we anticipate reporting topline 24-week data by early next year. We also anticipate completion of a second Phase 2 trial with elvucitabine in patients infected with the M184V strain of HIV by the end of the year, with results to be announced soon thereafter. In the meantime, we believe the results announced today will stimulate more advanced discussions with potential collaboration partners on commercialization and fixed-dose formulation strategies, while forming the basis for additional meetings with the FDA to review registrational trial design."
About the Study
The Phase 2 clinical trial 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.
Elvucitabine, Achillion's lead 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 one 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.
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 www.achillion.com or call Achillion at 1-203-624-7000.
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, the Company's expectations regarding the release of data from ongoing clinical trials and its beliefs regarding the effect of the results of collaboration discussions. 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. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2006. 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.
This news release was distributed by PrimeNewswire, www.primenewswire.com
SOURCE: Achillion Pharmaceuticals, Inc
Achillion Pharmaceuticals, Inc. Investors: Mary Kay Fenton (203) 624-7000 MacDougall Biomedical Communications, Inc. Media: Christopher Erdman (508) 647-0209
(C) Copyright 2007 PrimeNewswire, Inc. All rights reserved.
News Provided by COMTEX
Posted: October 2007