UPDATE ON PROGRESS OF BIT225 PHASE 2 HIV-1 CLINICAL TRIAL
Published: Aug 07, 2018
Sydney, Australia, August 7, 2018: The Directors of Biotron Limited (ASX: BIT) are pleased to provide an update on the progress of the company’s proof-of-concept HIV-1 clinical trial.
The trial is a Phase 2, multi-centre, randomised, placebo-controlled, double-blind study of Biotron’s lead molecule, BIT225, and Combination Antiretroviral Therapy (cART): Atripla® in patients with Human Immunodeficiency Virus (HIV-1) infection. HIV-1-infected patients had not previously been on anti-HIV-1 treatment (i.e. treatment naïve) and were commencing a cART regimen (approved anti- HIV-1 drugs). Patients received cART in addition to 12 weeks with BIT225 or placebo.
The objectives of the trial are to assess:
- Impact of BIT225 in combination with cART on plasma and intracellular HIV-1 virus levels, and;
- Impact of BIT225 on HIV-1-induced immune activation.
Biotron has previously advised that a novel diagnostic assay is being utilised to demonstrate the potential impact of BIT225 on HIV-1 virus levels. The Company had expected results from this highly specialised virology assay to be available by mid 2018.
This work is being done by a third party that has developed the assay and is completely independent from Biotron. They have indicated that there have been some delays due to other commitments and that the Biotron results are now expected by the end of September 2018. The samples and the results of the analyses remain blinded until this work is complete.
In parallel, analyses have been continuing to assess the impact of BIT225 on HIV-1-induced immune activation. Data from this key component of the trial have been compiled, and are being reviewed by an independent, internationally renowned HIV immunologist based in Europe. It is expected that this review will be available at the same time as the results from the virology assay.
Dr Michelle Miller, Biotron’s CEO and Managing Director noted “The virological assay that has been developed is cutting edge, allowing us to look for the first time at active virus levels within specific reservoir cells. Together, the data from these virological and immunological assays have the potential to demonstrate that BIT225 can either protect or eliminate HIV-1 from monocytes. These are key elements in our strategy to demonstrate that BIT225 has the potential to form a key component of an overall “cure strategy” for HIV-1. While disappointed that there has been a delay, we look forward to reporting results from this exciting study as soon as possible.”
Peter J. Nightingale
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need. The Company has BIT225 in clinical development for HIV-1, and a promising preclinical program for HBV. In addition, Biotron has several earlier stage
programs designing drugs that target a class of virus protein known as viroporins which have a key role in the virus life cycle of a very broad range of viruses, many of which have caused worldwide health issues such as Dengue, Ebola, Middle East Respiratory virus, Influenza and Zika viruses.
Dr Michelle Miller
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