Tetra Bio-Pharma Sees High Volume Following COVID-19 Drug Review

Shares of CBD drug developer Tetra Bio-Pharma Inc. (TSX-V: TBP) jumped 1.5 cents on Thursday on 5.99 million shares following its announcement of the US FDA's favourable review of the company's prospective COVID-19 therapy.

The company says it is "extremely pleased" with the "positive feedback" received from the FDA in its review of Tetra's Pre-Investigational New Drug (PIND) application for ARDS-003, conducted within the framework of the government's Coronavirus Treatment Acceleration Program. Tetra says that the FDA agrees with the proposed active substance behind ARDS-003, and that it has given the go-ahead for Tetra's nonclinical program to test the drug's stability.

"The feedback received is extremely positive news," said Tetra Bio-Pharma CEO Dr. Guy Chamberland in the release, "because now we have confidence that the rodent and nonrodent species used in the nonclinical toxicology study will provide a relevant assessment of the safety profile of the new drug (ARDS-003) prior to first-in-human trials. The impact of this outcome will result in a decreased cost to run the drug development program because any human-specific metabolite or disproportionate metabolite requires additional toxicology testing and has a significant effect on the overall cost of and time to complete the program. This will allow us to design the program in such a way that we can potentially further increase shareholder value." He added that the company hopes to expedite trials on ARDS-003 as much as possible, and plans to start a phase 1 trial for COVID-19 patients this September.

ARDS-003 is designed to reduce lung inflammation that develops in sufferers of COVID-19, dampening the potentially deadly cytokine storm and preventing the onset of acute respiratory distress syndrome (ARDS). The company is competing with a number of others rushing to find a solution to the COVID-19 cytokine storm, but Dr. Chamberland says that ARDS-003 is different in that it's not being repurposed for the COVID-19 pandemic, rather that Tetra Bio-Pharma is "accelerating a drug development program of a drug designed to treat this type of serious health condition, … in-line with [its] goal to develop patent-protected innovative therapies for patients with serious health conditions."

Since entering the fray for COVID-19 drug development in April, shares of Tetra Bio-Pharma have dropped 6 cents. The stock is down 23 cents year-to-date and is now trading at 23 cents per share.

Shares of CBD drug developer Tetra Bio-Pharma Inc. (TSX-V: TBP) jumped 1.5 cents on Thursday on 5.99 million shares following its announcement of the US FDA's favourable review of the company's prospective COVID-19 therapy.

The company says it is "extremely pleased" with the "positive feedback" received from the FDA in its review of Tetra's Pre-Investigational New Drug (PIND) application for ARDS-003, conducted within the framework of the government's Coronavirus Treatment Acceleration Program. Tetra says that the FDA agrees with the proposed active substance behind ARDS-003, and that it has given the go-ahead for Tetra's nonclinical program to test the drug's stability.

"The feedback received is extremely positive news," said Tetra Bio-Pharma CEO Dr. Guy Chamberland in the release, "because now we have confidence that the rodent and nonrodent species used in the nonclinical toxicology study will provide a relevant assessment of the safety profile of the new drug (ARDS-003) prior to first-in-human trials. The impact of this outcome will result in a decreased cost to run the drug development program because any human-specific metabolite or disproportionate metabolite requires additional toxicology testing and has a significant effect on the overall cost of and time to complete the program. This will allow us to design the program in such a way that we can potentially further increase shareholder value." He added that the company hopes to expedite trials on ARDS-003 as much as possible, and plans to start a phase 1 trial for COVID-19 patients this September.

ARDS-003 is designed to reduce lung inflammation that develops in sufferers of COVID-19, dampening the potentially deadly cytokine storm and preventing the onset of acute respiratory distress syndrome (ARDS). The company is competing with a number of others rushing to find a solution to the COVID-19 cytokine storm, but Dr. Chamberland says that ARDS-003 is different in that it's not being repurposed for the COVID-19 pandemic, rather that Tetra Bio-Pharma is "accelerating a drug development program of a drug designed to treat this type of serious health condition, … in-line with [its] goal to develop patent-protected innovative therapies for patients with serious health conditions."

Since entering the fray for COVID-19 drug development in April, shares of Tetra Bio-Pharma have dropped 6 cents. The stock is down 23 cents year-to-date and is now trading at 23 cents per share.