Australian-based Biotron has begun the Phase II clinical trial (BIT225-009) of its anti-viral drug BIT225 to treat patients with human immunodeficiency virus (HIV-1) infection.
BIT225 is a new HIV-1 Vpu protein inhibitor developed to prevent virus replication in cellular reservoirs.
The multi-centre, randomised, placebo-controlled, double-blind Phase II trial will evaluate the drug and combination anti-retroviral therapy (cART) Atripla for 12 weeks.
Designed as a dose escalation study, a group of nine patients will receive 100mg BIT225 or placebo in combination with cART, while a second group of 27 patients will receive 200mg BIT225 or placebo with cART.
Biotron managing director Michelle Miller said: “Initiating this clinical trial is an important step towards demonstrating the clinical benefit that BIT225 could bring to the treatment of HIV-1.
"BIT225 has the potential to play a key role in the eradication of HIV-1 by targeting and clearing HIV-1 from cellular reservoirs. We expect to see early results from the trial in late Q3 this year.”
The primary objective of the trial is to determine the efficacy of the drug over the 12 week period by measuring plasma viral load decay and modelling HIV-1 decay, in addition to assessing its safety and tolerability.
The secondary outcomes will include its impact on the levels of a primary biomarker of monocyte immune activation called sCD163 and determination of pharmacokinetics.
Through the trial, the firm intends to demonstrate the drug's efficacy in reducing HIV-1 in combination with cART, as well as its role in targeting viral reservoirs not impacted by cART in order to decrease HIV-1-induced immune activation.