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Ambrilia says protease inhibitor PPL-100 safe, well-tolerated in study
By Elaine Rigoli
Tampa, Fla., June 15 - Ambrilia Biopharma Inc. announced results of a phase 1a clinical study for PPL-100, its lead protease inhibitor for the treatment of HIV/AIDS, which suggested PPL-100 was found to be safe and well-tolerated.
The pharmacokinetic profile also indicated that PPL-100 can be used as a first-line, un-boosted once-a-day protease inhibitor for protease inhibitor-naive patients.
The company said it predicts that PPL-100 can also be used as an un-boosted once-a-day protease inhibitor for protease inhibitor-experienced patients infected with drug-resistant HIV strains containing highly prevalent mutations.
The phase 1a study was a single-dose escalation study evaluating the safety and pharmacokinetic profile of PPL-100 in healthy male volunteers, according to a news release.
Evaluated were five doses of PPL-100 (300, 600, 1,200, 1,800 and 2,400 mg) in five cohorts of eight subjects per cohort (six receiving PPL-100 and two receiving a placebo).
Two amendments were added to the study, the first to assess the effect of combining a light meal to the 600 mg and 1,200 mg dose, and the second to investigate the effect of combining a light meal and a low dose of ritonavir (100 mg) to the 600 mg dose.
Subjects were again randomized to have six receive PPL-100 and two a placebo. Upon completion of the study, 64 subjects were treated.
Results confirmed PPL-100 to be safe and well-tolerated up to 2,400 mg with only mild (grade 1) adverse events reported for all cohorts, the release said.
The pharmacokinetic profiles were equally encouraging. The area under the curve and maximum plasma concentrations indicative of the absorption and metabolism of the drug were seen to increase linearly with increasing dose, the release said.
Ambrilia is a biopharmaceutical company with its head office, research and development and manufacturing facilities located in Montreal.
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