25 October 2018 and provide the following responses: 1. Did BIT set benchmarks to determine the success rate of the Phase 2 Trial? Yes. (6 pages by email) [NOTE – We define “benchmark” as a clinical trial objective when forming the answers to these questions. In some other situations, not relevant here, benchmark evaluation for HIV‐1 antiviral trials generally refers to the use of a standard result as a point of evaluating the performance of a new antiviral agent. BIT225‐009 trial was designed to measure the antiviral efficacy and safety of a BIT225. Its mode of action is the inhibition of HIV‐1 replication primarily in a subset of HIV‐1 infected cells called macrophages. This is a novel target where no benchmark antiviral agent has been investigated previously. This study was an exploratory study with multiple Objectives and end points measured. For the purpose of responding to these questions, we are using the words benchmark and objectives interchangeably.] 2. If the answer to question 1 is “yes”, please state (i) the end points to the benchmarks; (ii) whether the end points were reached; (iii) provision of the data to demonstrate these benchmarks were reached; and (iv) an explanation as to why this information was not disclosed in the Announcement. The BIT225‐009 Phase 2 clinical trial was designed to assess the safety and antiviral activity of three month’s dosing of BIT225 in combination with antiretroviral drugs in treatment‐naïve HIV‐positive subjects. This was a double‐blind, placebo‐controlled study undertaken at trial sites in Thailand. A total of 27 HIV‐infected subjects, who had not previously taken any antiretroviral drugs, took once daily doses of 200 mg BIT225 or placebo for 12 weeks in combination with antiretroviral drugs. At the end of 12 weeks, all continued to take antiretroviral drugs as per standard protocols. A smaller cohort of 9 subjects took once daily doses of 100 mg BIT225 or placebo; this cohort was set up for detailed pharmacokinetic profiling of the BIT225 and its interactions with antiretroviral drugs. The BIT225‐009 study has previously disclosed the Primary and Secondary Objectives as outline in the announcement to the ASX: “Commencement of BIT225 Phase 2 HIV‐1 Clinical Trial” lodged 9.36 am on 13 February 2017. As set out in that 13 February 2017 announcement, the aim of this Phase 2 trial was to demonstrate: • Accelerated reduction of HIV‐1 in patients treated with BIT225 in combination with cART, indicating that BIT225 can significantly improve current standard of care anti‐ HIV‐1 treatment; and
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