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clock Created with Sketch. 23/11/21
13:30
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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 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 • 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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I'm with optimist Moosey on this one. Not a sprint, a plod, yes, but sometimes, in fact reasonably often, the plodder saves the day.
(20min delay)