Ann: Quarterly Activities Report, page-2

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The latest data, reported on 17 March 2022, demons trated that BIT225 pr otected against COVID
related death in K18 transgenic mice (a strain generated to be infect able with SARS-CoV-2,
resulting in severe COVID) that were infected with a lethal dose of the virus. Control mice that
were not dosed with BIT225 al l died by Day 8 post-infection with SARS-CoV-2 from severe
COVID. In contrast, 100% of mice treated with BIT 225 continued to gain weight as per age
expectations and remained healthy through to Day 12 when the study was terminated.
As in the previous study announced in Novemb er 2021, the BIT225 treated mice once again had
significantly lower viral loads of SARS-CoV-2 in their lungs co mpared to drug free control
animals.
BIT225 belongs to a new class of antiviral drugs known as viropor in inhibitors. Viroporins are
virus-encoded proteins that ar e central to establishing and maintaining infections through
modulation of the body’s immune system. BIT225 is Biotron’s l ead antiviral, clinical stage,
investigational, orally-dosed smal l molecule drug that has been eval uated in nine clinical trials
involving healthy volunteer s, patients with HIV-1 in fection, patients co-inf ected with Hepatitis C
virus (‘HCV’ and HIV-1 and patie nts with HCV (as monotherapy and in combination with
pegylated interferon-alfa and ribavirin).
Despite the availability of SARS-CoV-2 vaccines, there remains a need for oral drugs to treat the
infection and prevent severe diseas e, especially in at-risk indivi duals. BIT225 has an established
human safety profile and has the potential to be an important first- in-class drug for COVID-19
treatment.
In consultation with its USA base d advisors and consultants, Biot ron has submitted a proposal to
the USA Food and Drug Administration (‘FDA’ to conduct a human clinical trial to assess the
efficacy of BIT225 for the treat ment of COVID-19 under the Coronavirus Treatment Acceleration
Program, a special emergency program for potential coronavirus therapies.
Guidance from the FDA will inform the final design of a suitable international trial and will be a
key component of the Company’s outreach to potential partners.
HIV-1 Program
During the quarter ended 31 March 2022, Biotron has continued recruitment of the two previously
announced Phase 2 clinical trials of BIT225 for treatment of HIV-1 infection.
One of the trials (BIT225-011) wi ll investigate the impact of BI T225 in HIV infected people who
have been taking approved anti-HIV-1 treatment (‘ART’ for an extended period with well
controlled HIV-1 infection but who have not achieved full immune reconstitution despite long term
durably suppressive ART.
This group, estimated to encompas s more than one thir d of the HIV treated population, is at an
increased risk of clinical prog ression to AIDS and other morb idities and has higher rates of
mortality than HIV infected patients who have attained full immune reconstitution. The trial is in
progress at sites in Sydney, Australia including St Vincent’s Hospital and Holdsworth House.
The second trial (BIT225-010), which is underway at sites in Thailand, includes people newly
diagnosed as being HIV-1 positive but who have not yet commenced ART. The trial will continue
with BIT225 treatment or placebo continuing for 6 months in combination with ART.