Shares in the small-cap biotech jumped 37.5% to 9.9 cents each after reporting positive COVID-19 animal trial results today.
Biotron Limited is engaged in the research, development, and commercialization of drugs targeting significant viral diseases with unmet medical need. The company said that it’s lead clinical drug BIT225 protected mice that have SARS-CoV-2 from severe disease.
This test was trickier than an earlier one the company conducted. In the latest test, the mice were infected by SARS-CoV-2 for up to 48 hours before being treated with BIT225. In the earlier study, the mice were given BIT225 12 hours before being infected by SARS-CoV-2.
The second trial was more challenging as it had a higher hurdle to demonstrate the efficacy of the drug, according to Bitotron.
Biotron’s Managing Director, Michelle Miller, said:
The results from this new study are important as they show a clear clinical benefit for BIT225 regardless of time of commencement of treatment. We believe that BIT225’s extended therapeutic protection window sets it apart from other approved or in-development agents and further strengthens our confidence in this valuable clinical asset.
In fact, Biotron claims that this characteristic is a requirement for successful product development in this therapeutic area.
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.
There were five mice in each of the pre-dose and post-dose groups. There was also a control group with the same number of mice. In the groups that were treated with BIT225, all but one remained healthy and continued to gain weight as per age expectations through to Day 12 when the study was terminated. One of the five mice in the post-dose group died on Day 11 of the trial. In the control group made up of untreated mice, all lost weight and died by day eight of the study.
The company noted that there was less weight gain if BIT225 treatment was delayed. But the trend lines are statistically similar regardless of when the drug was used. 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.
In March 2022 the Company 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. A response is expected shortly and, once received, the Company will be in a position to determine its capital requirements for the human clinical program funding which will be sought from potential partners and non-equity funding sources, the company said.