Lawson Health Research Institute says enrolment for the clinical trial is already underway, with a goal of including 60 critically ill COVID-19 patients.
If the trial results show promise, Lawson scientist Dr. Qingping Feng’s team plans to expand to a larger phase III trial involving “not just COVID-19 patients with sepsis, but other sepsis patients as well.”
Sepsis is a potentially fatal condition wherein the body overreacts to an infection, leading to an overwhelming inflammatory response that can damage the heart, liver, lungs, or brain.
The clinical trial will look at the effectiveness of a treatment using a manufactured form of a human protein called annexin A5, which is believed to help reduce inflammation and coagulation.
“The annexin basically forms this protective coating over the top of (injured cell membranes), which shelters that cell from triggering the immune response,” Lawson associate scientist Dr. Claudio Martin told Global News.
“The other part that that coating can do is probably reduce the sticking of platelets, the component of blood that causes blood clots.”
The potentially groundbreaking drug has been more than two decades in the making.
Feng began working on sepsis research at Victoria Hospital in 1997 and started focusing on annexin A5 roughly 13 years ago.
A pre-clinical study showed promising results when treating sepsis in animal models.
Last fall, Feng’s team said annexin A5 could be effective in 40 per cent of cases — a huge increase from the current best available approach, which Lawson said works six per cent of the time.
Martin says the team began organizing for the clinical trial in the fall but had to wait for preliminary safety studies on the drug.
“It is a brand new medication that’s never been used in humans before. So those studies had to be completed before we could move on to this phase of the of the investigation,” Martin says, referencing the start of the human clinical trial.
“It’s been a long time coming but we finally started enrolling patients back in April with the third wave of COVID.”
Patients enrolled in the study will receive standard treatment as well as either a lower dose of annexin, a higher dose of annexin, or a placebo.
Martin says the current plan is to enrol patients as they come in, likely wrapping up in the fall and analyzing results, before hopefully launching a larger clinical trial.
“We think that this drug might be beneficial not just for COVID-related sepsis, but for sepsis in general. So we would have to go back and rejig the study design a little bit, get Health Canada (approval).”
The drug is being produced through a partnership with Lawson Health Research Institute, WORLDiscovieres (the business development arm of research involving Western University, Robarts Research Institute and Lawson), and China-based Suzhou Yabao Pharmaceutical R&D Co., Ltd.
“Our long-standing partnership with Suzhou Yabao has enabled annexin A5 drug development to proceed to this point,” Lawson manager of business development Kirk Brown said in a statement.
“We are now in a unique position through this trial to offer a potential life-saving treatment for this emergent global disease, with the objective of soon expanding to all cause septic patients.”
— With a file from Global News’ Saba Aziz.
Meet Dr. Cepinskas, researcher at Lawson and Western University Schulich School of Medicine, Dentistry
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