Bit225 Effective Against Established Sars-Cov-2 in Animals

The Directors are pleased to advise that the Company’s lead clinical drug, BIT225, has demonstrated effective protection from severe disease in mice with established SARS-CoV-2 infection in a new animal study performed at The SCRIPPS Research Institute, La Jolla, CA, USA.

• In a significant step forward, new data shows that BIT225 protects from severe disease even when started once there is an established infection.
• Mice commencing treatment with BIT225 after infection with SARS-CoV-2 had similar levels of protection against severe disease as mice commencing treatment with BIT225 prior to infection.
• The results are important as they provide key information that will assist in determining the dosing regimen for BIT225 in planned human clinical studies.
• The results further extend the robust in vivo data package that shows statistically and clinically significant efficacy of BIT225 in both treatment and prevention in murine models of COVID-19.

In previously reported studies (17 March 2022 and 25 November 2021), animals were dosed with BIT225 12 hours before infection with SARS-CoV-2. In this new study, the animals were infected with SARS-CoV-2 up to 48 hours before starting treatment with BIT225.

This is a more challenging model and creates a high hurdle to demonstrate efficacy of the drug.

In all studies, BIT225 was tested in a human-adapted COVID-19 mouse model (K18-hACE2) that is routinely used to assess the ability of drugs to target SARS-CoV-2 and treat COVID-19 disease.

The experimental details, set out in the Addendum below, show that BIT225 can both prevent and treat SARS-CoV-2 disease - necessary requirements for successful product development in this therapeutic area.

All BIT225 pre-dosed mice (n=5) and 24-hour post-dose mice (n=5) remained healthy and continued to gain weight as per age expectations through to Day 12 when the study was terminated. One of the five animals in the 48-hour post-dosing cohort died on Day 11 of the study. As in previous studies all vehicle-control mice showed an inexorable downward trend in body weight, and all control mice (n=5) died by Day 8 (Figure 1 below).

Group mean body weights of BIT225-treated mice throughout the studies (a reflection of COVID-19 disease) were statistically different to vehicle control mice throughout the study (Figure 2 below). While there appears to be a trend for less weight gain if initiation of BIT225 dosing is delayed, the trend lines are statistically the same regardless of whether drug treatment was initiated pre-infection or post-infection.