Biotron (ASX:BIT) says its lead clinical asset BIT225 has again demonstrated substantial and clinically meaningful efficacy against SARS-CoV-2 in a series of animal studies performed at The SCRIPPS Research Institute in the US.
"BIT225 protected against severe disease, indicated by the significant prevention of body weight loss and absence of death in SARS-CoV-2-infected animals treated with BIT225 compared to non-treated controls," said the company.
BIT225 was tested in a 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.
According to managing director Michelle Miller, “The results from the extended, repeat Study 2 confirm the results from Study 1, showing a clear clinical benefit from the treatment with BIT225.
"Supported by these results, and in consultation with USA based advisors and consultants, Biotron 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 treatment of COVID-19 under the Coronavirus Treatment Acceleration Program, a special emergency program for potential coronavirus therapies.
"Funding the clinical development of BIT225 for this indication will be sought from potential partners and non-equity funding sources.”