Idenix Pharmaceuticals (IDIX)

[DewDiligence]

Here’s the full PR on IDIX’s HIV candidates.
JP has characterized these compounds (which
are essentially two formulations of the same
drug) as next-generation Sustivas. If they could
be that, it would be quite a coup for IDIX
because Sustiva is one of the top-selling HIV
drugs and is a component of the 3-in-1 Atripla
pill. Obviously, there is a long way to go.

http://biz.yahoo.com/prnews/070301/clth039.html?.v=89

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Preclinical Data From Two Novel Idenix Compounds for the Treatment of HIV Presented at Conference on Retroviruses and Opportunistic Infections (CROI)

Thursday March 1, 4:05 pm ET

CAMBRIDGE, Mass., March 1 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), 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/.
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