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.

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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.

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"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.”

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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.