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news.Ambrilia Biopharma has announced that the latest findings on its lead HIV protease inhibitor, PPL-100 show the treatment candidate to be safe and well tolerated, with a favorable pharmacokinetic profile.
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Safety assessment confirmed PPL-100 to be safe and well tolerated at up to a 2400mg oral dose with only mild (grade 1 and 2) adverse events reported for all cohorts. The pharmacokinetic (PK) profile, meanwhile, indicates drug exposure; area under the curve (AUC) increased linearly with doses. Maximum plasma concentrations (Cmax) of the drug increased linearly until 1200mg and less thereafter.
The clinical data indicate that the most striking characteristic of PPL-100 is its long elimination half-life (30 to 37 hours), which supports once-daily dosing. Finally, the data indicate that there is no significant difference in drug exposure in the absence or presence of a light meal, suggesting that PPL-100 can be administered without regard to food, giving patients added convenience.
Using final clinical data from the first-in-man single dose escalation studies, scientists at the Institute of Clinical Pharmacodynamics (ICPD), Ordway Research Institute, New York, conducted population pharmacokinetic (PK) modeling and pharmacokinetic-pharmacodynamic (PK-PD) target attainment analyses.
Modeling and simulation results predict a favorable steady-state PK profile for PPL-100, suggesting that it could be a first-line, once-daily protease inhibitor (PI) without the need of ritonavir (a boosting agent) co-administration for the treatment of both PI-naive and experienced HIV/AIDS patients infected with highly resistant strains of the virus.
These analyses also indicate that PPL-100 offers excellent ‘forgiveness’ in the event of a missed dose, an important characteristic to address the non-adherence issues in HIV therapy.
Ambrilia said that it believes PPL-100 could be an asset to both physicians and patients in the fight against HIV/AIDS by potentially addressing the need for safer, more convenient and effective PIs.
The company presented the final phase Ia data and pharmacokinetic modeling and target attainment analysis results at the 16th International AIDS Conference.