Sequoia Pharmaceuticals Presents Proof of Clinical Concept of SPI-452, a Novel Pharmacokineti...(minimumplasma concentrations (Cmin) at 1...),Health

Date:2/9/2009

minimum plasma concentrations (Cmin) at 12 and 24 hours up to 37-fold of darunavir and up to 13-fold of atazanavir. SPI-452 given alone demonstrated that steady- state drug levels were achieved by day 14 and that SPI-452 levels increased slightly greater than linearly with dose. SPI-452 was generally safe and well tolerated when dosed up to 200 mg once daily for 15 days. No subjects withdrew from the study because of study drug, and no serious adverse events (AEs) were reported. AEs were usually mild in severity with no pattern of body-system AEs. The most common AEs reported were headache, nausea/emesis and diarrhea. Furthermore, there were no statistically significant changes in triglyceride and LDL cholesterol levels in subjects receiving SPI-452 compared with placebo, which may indicate that SPI-452 has a favorable lipid profile.

"SPI-452 represents an extremely promising PKE with the unique ability to boost levels of protease inhibitors without conferring any inherent antiviral activity, a distinguishing feature that would allow SPI-452 to be combined with PIs in HIV or HCV treatment," said Joseph Eron, MD, professor and director of the AIDS Clinical Trial Unit and Center for AIDS Research at the University of North Carolina at Chapel Hill. "These data support the further development of SPI-452 as a potential alternative to ritonavir."

Study 0452-001: First Time in Humans

Results were also presented from an earlier first-time-in-human study where fifty-eight healthy volunteers took part in a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of SPI-452 administered alone and in combination with 1000 mg of saquinavir (SQV). In part 1 of the study, subjects received single doses of SPI-452 (25 mg, 50 mg, 100 mg, 200 mg, 400 mg or 600 mg). In part 2, subjects received SPI-452 (50 mg or 200 mg)
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