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
it with focus on partner requirements
• 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
undergoing preliminary safety testing
Key Achievements 2020/2021 FY (cont)
• 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
the body’s immune system to fight the infection
• Focus is on partnering
HIV-1 Unmet Need
• Safe, effective antiretroviral drugs (ART) have been central to successfully keeping virus levels down in HIV+
people; Profound reductions in mortality, morbidly and transmission
BUT
• ART is not curative, latent viral reservoirs remain
and reactivate
• Immune reconstitution is only partial and
accompanied by a state of chronic inflammation
• A significant excess of chronic diseases,
malignancy and neurocognitive deficits result in
individual and societal burdens
• Global treatment costs are not remotely
sustainable
SARS-CoV-2 Program
Vaccines remain central to control of the pandemic but there is an urgent need for effective drugs to treat COVID in at-risk
populations
• 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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