Ann: Full Year Statutory Accounts, page-8

Eradication of virus from hidden reservoirs is key to further improving health outcomes in this population and also key to any strategy to cure patients infected with HIV-1.In mid-2020, Biotron presented additional data on BIT225 at the 23rd International AIDS Conference (AIDS 2020). The data showed how BIT225 directly modifies immune responses to HIV-1 infection and helps explain the positive immune changes that were reported in the Phase 2 clinical trial. The data help to explain how BIT225 “unmasks” HIV-infected cells and promotes immune recognition of the virus. Immune system recognition initiates the host defence processes including the clearance of virus. In combination with results from the Phase 2 clinical trial, these latest results support further clinical study of the potential anti-viral and immunological benefits of BIT225 therapy in combination with ART.BIT225 is unique. It is the first of its kind to act as both a direct-acting antiviral drug and an immune enhancer. Taken together, the research undertaken over the last 12 months has provided a more detailed understanding of how the addition of BIT225 to anti-HIV-1 drugs stimulates the body’s immune system so that it can find HIV- infected reservoir cells and take the necessary steps to eliminate any residual virus. This effect of “unmasking” infected cells within cellular reservoirs would solve a huge problem in treating HIV-1 by allowing the body's immune system to work together with the anti-HIV drugs to clear out inaccessible pockets of virus and annihilate the infection for good – opening up the potential for HIV-infected people to avoid lifetime drug treatment.Since the end of the year in review, in July 2020 Biotron appointed Stephen Becker MD as Chief Medical Officer (CMO) to oversee the next stage of BIT225’s clinical development. Dr Becker has extensive experience as a product development executive, clinician and researcher with specific focus on the therapeutic areas of HIV, infectious diseases and immunology. Based in the USA, he brings solid clinical experience plus years of experience in a similar role in the industry, as well as time in a senior role with the Bill & Melinda Gates Foundation.Dr Becker’s connections with pharmaceutical companies, USA government organisations, philanthropic organisations, as well as his knowledge of regulatory and policy issues relating to development and approvals of new drugs bring essential skills at this critical stage of the Company’s development.Dr Becker’s appointment follows on from the establishment during the first half of the financial year of an expert Scientific Advisory Board (SAB) for its HIV-1 clinical development program. The SAB is an international group of experts with broad experience within the HIV-1 field, covering clinical development of HIV-1 therapies. The members are highly regarded by academia and industry and have experience advising pharmaceutical industry on new treatment strategies, including HIV-1 cure. The group augments the support that Biotron receives from key opinion leaders, academics and industry participants across its antiviral programs and will be central to the development of Biotron’s lead drug, BIT225.The existing Phase 2 trial data are showing us and, importantly, potential partners how BIT225 may play a role in the eradication of HIV-1. The results are encouraging and may have profound implications for the future treatment and cure of HIV-1 infection.The next step in the development of BIT225 is to refine how it should be used in the clinic, based on the latest data. This will likely require a Phase 2b clinical trial to convert the statistically significant immune markers changes seen in the completed Phase 2 trial into statistically significant changes in clinical outcomes. The recent completion of long-term toxicology studies of BIT225 is an important milestone as they support long- term dosing of BIT225 in the next stage of clinical development and beyond. The expertise of the Company’s CMO and the SAB, together with feedback from industry and regulatory agencies are central to mapping out this next stage of development.The Company is focused on achieving a commercial outcome for its promising antiviral programs whilst continuing to progress its clinical HIV-1 program to prepare for more advanced clinical trials.