Biotech firms are typically the long-haulers of the entrepreneurial set, and Tetra Bio-Pharma is no exception.
For years, scientists at the Orléans-based company have been patiently toiling away on a drug that provides the anti-inflammatory benefits of CBD, a therapeutic ingredient found in cannabis, but without some of the side effects that can include nausea, headaches and fatigue.
After millions of dollars’ worth of research and tens of thousands of hours of painstaking effort, Tetra founder Guy Chamberland and his team say the product is on the cusp of finally being ready for market – and not a moment too soon.
Called ARDS-003, Tetra’s synthetic drug is designed to treat sepsis and acute respiratory distress syndrome, life-threatening conditions triggered when the body’s immune system “goes rogue” in response to an infection such as COVID-19 and begins attacking healthy cells as well as harmful bacteria and viruses.
The result is often what’s called a “cytokine storm.” Small molecules released by the immune system, cytokines move throughout the body to co-ordinate an immune response to an inflection. But if the immune system kicks into overdrive, the resulting inflammation can cause organ failure and severe respiratory illness as the lungs fill with fluid.
That’s where Tetra’s breakthrough research comes in. Chamberland says the drug effectively blunts the severity of the exaggerated immune response that often occurs in patients suffering from COVID-19, cancer and other diseases, thereby reducing the likelihood of deadly consequences such as sepsis and ARDS.
"After 12 years of research, we’re pretty confident this is going to be a successful drug."
“That’s what this drug is designed for,” says Tetra’s CEO, who has a PhD in toxicology from the University of Montreal. “After 12 years of research, we’re pretty confident this is going to be a successful drug. The manufacturing of this is going to be huge.”
With the opportunity it’s been chasing for years now within reach, Chamberland says Tetra has all the pieces in place to start mass-producing ARDS-003 as soon as it gets the green light for emergency use from regulators in Canada and the U.S.
The company has signed a deal with Toronto-area pharmaceutical company Dalton Pharma Services to manufacture the drug, and Tetra’s scientists conducted a series of toxicology studies last year to pave the way for expedited human clinical trials that are expected to begin within weeks in Canada and the U.S.
Chamberland says that if all goes according to plan, the drug could be in hospitals across Canada before the end of the year. He says the pandemic has opened up a clear path to rapid regulatory approval, compressing timelines of six months or more into mere weeks as health agencies rush to get effective treatments on the market.
“As a business, we saw that we could take this drug from start to finish ... in record time,” he explains. “My challenge now is to get ready. If I have a successful drug in patients, I need to be ready to supply it at least to Canada.”
Of course, scaling up production and pushing its research agenda won’t come cheap for Tetra.
The publicly traded firm, which employs about 40 people in Ottawa, Montreal, Moncton and Halifax, boosted its cash reserves this week when it closed a bought-deal share offering led by Canaccord Genuity and Leede Jones Gable that raised nearly $14.5 million. Tetra is also seeking more government funding to help accelerate its R&D campaigns.
Chamberland says the firm plans to continue working closely with research partners such as Nova Scotia’s Dalhousie University and George Mason University in northern Virginia in a bid to develop more groundbreaking therapeutics.
Meanwhile, he expects demand for ARDS-003 will only increase even after the current health crisis abates.
While COVID-19 presents the most obvious and immediate use case for the drug, Chamberland notes that sepsis and ARDS will remain global health threats long after the novel coronavirus is contained. Sepsis alone kills more than 14,000 Canadians a year and millions of people around the world.
“Other viruses are going to come,” he adds. “As a society, we have to be ready.”