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clock Created with Sketch. 23/11/21
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Originally posted by moosey
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Key Achievements 2020/2021 FY Key milestone for HIV-1 program: Commenced two clinical trials of BIT225 Trials designed in consultation with international experts with key links to pharma Designed specifically to solidify understanding of what BIT225 is doing and how it is doing There is no roadmap to follow for HIV cure/eradication Trials are being done to generate data to support future regulatory filings/use labels Completed a new manufacturing of BIT225 clinical-grade (cGMP) drug for future trials Progressed identification of next-generation HIV-1 drug candidate –candidates are currently Expanded the SARS-CoV-2 program Testing in relevant, robust animal model of COVID in USA laboratory Results are imminent Hepatitis B Virus (HBV) program Progressed identification of potential lead to move into animal model(s) Unique approach to tackling virus infections Combining direct antiviral and immunomodulatory activities to knock down virus levels and boost Focus is on partnering HIV-1 Unmet Need Safe, effective antiretroviral drugs (ART) have been central to successfully keeping virus levels down in HIV+ ART is not curative, latent viral reservoirs remain Immune reconstitution is only partial and A significant excess of chronic diseases, Global treatment costs are not remotely SARS-CoV-2 Program Designed and synthesised >100 new compounds to target the SARS-CoV-2 E protein (oral drugs) Screened for ability to inhibit replication of SARS-CoV-2 in a range of cell culture models Lead series identified based on these studies Several compounds with good antiviral activity in these in vitro studies IN PROGRESS: Testing key compounds in an animal model of SARS-CoV-2 in the USA Assessing immunomodulatory activity in parallel with antiviral activity Running preliminary preclinical safety studies in parallel Data expected before end 2021
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• HIV-1 program is the prime focus • Clear clinical development program designed to demonstrate to regulators and pharma how the drug may be used to improve health outcomes in combination with ART • SARS-CoV-2 program is developing drugs with potential to reduce virus levels and immune dysfunction seen in moderate to severe COVID. Aim is to progress these as quickly as possible through relevant models and into formal safety studies. • Hepatitis B (HBV) remains a promising and important early-stage program and good progress has been made to select a robust lead candidate • Biotron clearly has a portfolio of antivirals which uniquely combine antiviral inhibition with immunomodulatory activity. • All activities are undertaken with aim of generating data for partners.
