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Be the first with the news that moves the market- Biotechnology company, Arch Biopartners (TSXV:ARCH) has submitted an Investigational New Drug application to the US FDA
- The application is for a Phase II trial of the company’s drug, Metablok, on inflammation and injuries in COVID-19 patients
- Metablok may prevent symptoms of severe COVID-19, such as acute respiratory distress, and acute kidney and liver injuries
- The Phase II trial, which Health Canada has already cleared to proceed, will hopefully commence in the summer of 2020
- Arch Biopartners (ARCH) is down 0.69 per cent and is currently trading at C$1.44 per share
Biotechnology company, Arch Biopartners (TSXV:ARCH) has submitted an Investigational New Drug application to the US FDA.
The application is for a Phase II trial of the company’s lead drug, Metablok. If approved, Arch Biopartners will test the drug against inflammation and injuries in COVID-19 patients.
The company submitted the application after the Food and Drug Administration reviewed its plans for a Phase II trial. The FDA spent several weeks reviewing the plans, under the Coronavirus Treatment Acceleration Program.
Arch Biopartners safely completed dosing of its Phase I human trial of Metablok back in mid-March. The company also reported encouraging results of the drug’s effects in mice, at the end of March.
While Metablok is not a cure for COVID-19, it has the potential to significantly reduce or prevent some symptoms. Hospitalised COVID-19 patients with severe cases often present with acute respiratory distress syndrome, acute kidney injury, and acute livery injury.
Metablok has already demonstrated the ability to prevent lung inflammation in mice, suggesting it may also do so in humans.
If so, this could reduce COVID-19 fatalities and ICU admissions until a vaccine for the virus becomes available. It may also reduce the number of COVID-19 patients who require medical ventilators in order to survive.
Health Canada has already cleared the Phase II trial to go ahead. The trial will be a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study.
Assuming that the company receives FDA approval, the trial will start in the summer of 2020.
Arch Biopartners (ARCH) is down 0.69 per cent and trading at C$1.44 per share at 12:03pm EDT.
