CAMBRIDGE, Mass., March 1 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, announced today that preclinical data from two novel non-nucleoside reverse transcriptase inhibitors (NNRTIs) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, IDX899 and IDX989, demonstrated potent and selective activity in vitro. These data were presented today by Dr. Douglas Richman at the 14th Conference on Retroviruses and Opportunistic Infections (CROI) in Los Angeles.
“NNRTIs are a critical part of combination antiviral regimens for the treatment of patients with HIV-1 infection,” said Dr. Douglas Richman, Professor of Pathology and Medicine, University of California San Diego, and Director of the UCSD Center for AIDS Research. “However, rapid emergence of NNRTI-resistant virus remains a challenge of therapy today. New treatments are needed that offer an enhanced resistance threshold with potential for once-a- day oral dosing for HIV-1 infected individuals. These preclinical data are encouraging and I look forward to the further evaluation of this program in clinical testing.”
Preclinical data for IDX899 and IDX989 demonstrated activity against a broad panel of wild-type HIV-1 isolates. Potency was retained against panels of clinical isolates containing various single and double NNRTI mutations. Both compounds exhibited good oral bioavailability with a favorable pharmacokinetic profile. A favorable toxicology profile was also reported as genotoxicity studies were negative and no major adverse effects were observed in acute toxicity studies. IDX899 and IDX989 showed inhibition of CYP450 3A4, 2C8 and 2C9. Preliminary clinical evaluation of both Idenix compounds has been conducted under an exploratory Investigational New Drug (IND) application. A lead candidate, IDX899, has been selected for further clinical development based on its overall profile and IDX989 will remain a back-up candidate.
Dr. Richman’s poster presentation will be available on the CROI website at http://www.retroconference.org/2007/.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix’s current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as “encouraging”, “potential”, “favorable” or similar expressions or by expressed or implied statements with respect to the ongoing and planned clinical trial development of any of Idenix’s investigational products or development programs in HIV, hepatitis B or C, or any potential pipeline candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Idenix will successfully advance any clinic product candidate or other component of our potential pipeline. In particular, management’s expectations could be affected by the unexpected regulatory actions or delays; uncertainties relating to results of clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; the company’s dependence on its collaboration with Novartis Pharma AG; the ability of the company to attract and retain qualified personnel; competition in general; and the company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its other product candidates and its discoveries. These and other risks, which may impact management’s expectations are described in greater detail under the caption “Risk Factors” in the company’s quarterly report on Form 10- Q for the quarter ended September 30, 2006 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company’s expectations only as of the date of this release and should not be relied upon as reflecting the company’s views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals’ Contacts:
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
Idenix Pharmaceuticals, Inc.
CONTACT: Media, Teri Dahlman, +1-617-995-9905, or Investors, Amy Sullivan, +1-617-995-9838, both of Idenix Pharmaceuticals, Inc.