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DewDiligence

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Re: genisi post# 65195

Monday, 08/11/2008 3:41:50 PM

Monday, August 11, 2008 3:41:50 PM

Post# of 252642
Non-Nucleoside HIV Drugs Show Promise in Early Trials

[The two protagonists here are IDX899 from IDIX and RDEA806 from RDEA, both of which are candidates to supersede Sustiva as the sole non-nuke in 3-drug SoC cocktails. Both drugs performed well in terms of tolerability and antiviral activity.]

http://www.medpagetoday.com/MeetingCoverage/IAC/tb/10504

›By Ed Susman
August 11, 2008

MEXICO CITY, Aug. 11 -- Two investigational non-nucleoside reverse transcriptase inhibitors have showed promising results in suppressing HIV, found preliminary trials.

The two new drugs, IDX899, made by Idenix Pharmaceuticals of Cambridge, Mass., and RDEA806, made by Ardea Biosciences of Carlsbad, Calif., both showed potent activity in seven-day data, presented at the 17th International AIDS Conference here.

IDX899 resulted in a 1.8 log10 decline in HIV at three different doses, reported Carlos Zala, M.D., of the University of Buenos Aires.

Dr. Zala and colleagues at the Hospital Privado Modelo in Buenos Aires recruited 30 patients with no history of an AIDS-defining illness who registered a plasma HIV viral load equal to greater than 5,000 copies/mL and who were naive to treatment with antiretroviral medications.

Eight participants were assigned to each of three doses of IDX899 -- 800 mg, 400 mg and 200 mg -- all of which were taken once daily. Six patients were randomly assigned to a placebo arm.

In all the dose ranges, the fall in HIV levels was similar, Dr. Zala said. In all three doses, CD4-positive cell counts increased about 62 cells/mm3 while the cell count dropped by 80 among placebo patients. Dr. Zala said, however, that he was uncomfortable in considering those changes a treatment effect because of normal fluctuations in CD4-cell counts that one might see in a week.

"We did not see any treatment-emergent serious side effects and there were no premature discontinuations," Dr. Zala said. "The laboratory profiles were similar between IDX899 and placebo."

In the second study, Graeme Moyle, M.D., M.B.B.S, director of HIV Research Strategy at Chelsea and Westminster Hospital in London, described a similar seven-day study with RDEA806 in a phase IIa trial, which showed similar results as IDX899.

He recruited 48 patients. Nine were assigned to RDEA806 at a dose of 400 mg twice a day; nine were assigned to RDEA806 at 600 mg once daily; nine were assigned to RDEA806 at 800 mg once daily; nine were assigned to RDEA806 at 1,000 mg once daily. Twelve patients (three per cohort) were assigned placebo.

With the exception of the 600 mg dose, all other active-treatment groups showed a mean drop of 1.8log10 in viral load -- but the decrease was maintained through day 10 of the trial, despite the patients being off treatment. After day 10, HIV viral levels rebounded to baseline. Changes in HIV levels among the placebo patients were minor, Dr. Moyle said. Patients on the 600 mg once daily dose achieved a 1.3 log10 decline in viral load. [The 600mg qD dose has been discontinued.]

"We saw no clinically significant laboratory findings and no clinically relevant electrocardiography findings," he said.

Both RDEA806 and IDX899, in preclinical trials, appeared to be effective against strains of HIV that have gained resistance against efavirenz (Sustiva), the non-nucleoside reverse transcriptase inhibitor that is the standard of care for first-line treatment of HIV infection.

"RDEA806 was well tolerated and showed robust antiviral effect at all doses," Dr. Moyle said.

"These drugs look promising," commented John Mellors, M.D., of the University of Pittsburgh. "But no drug gets better with time. We need to see how these drugs fare in later trials."

He speculated that if they continue to show activity and lack of serious side effects he could imagine them being co-formulated with other drugs, "possibly creating a better Atripla (the fixed dose combination of emtricitabine, tenofovir, and efavirenz)." [exactly what IDIX intends to do with IDX899: #msg-26800695].‹



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“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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