COVID-19 patient with sepsis receiving Annexin A5 intravenously.
It’s a discovery that has been more than ten years in the making: the use of a human protein to potentially treat patients with sepsis.
Lawson Scientist Dr. Qingping Feng noticed that a human protein called annexin A5 showed positive results with sepsis back in 2007.
Fast forward 14 years later to now, and this discovery could very well be the first ever viable treatment for sepsis patients, including severe COVID-19 patients who develop sepsis. “With COVID initially, it is in the airway and then in the lungs, then from there the inflammatory response in fact spreads to the whole body,” says Dr. Feng, Ivey Chair in Molecular Technology at Western University’s Schulich School of Medicine & Dentistry. “Sepsis causes major organ dysfunction and carries a high mortality unfortunately.”
It has become a challenging issue for Intensive Care Physician at London Health Sciences Centre (LHSC), Dr. Claudio Martin, who can only do so much to treat severe COVID-19 patients that develop sepsis.
“What we have seen is a very primary severe respiratory failure to the lungs for severe COVID patients,” says Dr. Martin, Associate Scientist at Lawson. “We have used steroids and other treatments to try to help, but the results and effects aren’t dramatic and we see patients who have these treatments and still progress and end up in the ICU.”
However, Dr. Feng and his team has found in a pre-clinical study, that annexin A5 can inhibit inflammation, improve organ function, and survival when treating sepsis.
Another potentially deadly situation for COVID-19 patients is cell death and blood clots, specifically near the lungs. The good news is that the research team also believes the annexin A5 drug will prevent these complications through the drugs anti-apoptotic (cell death prevention) and anti-coagulant (blood clot prevention) properties.
Supported by provincial funding through Ontario’s COVID-19 Rapid Research Fund, the research team has launched a clinical trial with critically ill COVID-19 patients at LHSC, using a manufactured form of annexin A5. The goal is to enroll a total of 60 patients for the clinical trial, and enrollment has already begun. “Patients are receiving standard treatment and then those enrolled will also receive the annexin,” says Dr. Martin. “It’s a placebo blinded clinical trial, so patients will either get a lower dose of annexin, a higher dose of annexin, or a placebo.”
If the clinical trial shows promising results, Dr. Feng says the team plans on expanding into a larger phase three trial with not just COVID-19 patients with sepsis, but other sepsis patients as well. “If in fact annexin A5 is shown to be effective in sepsis, then this will be a huge benefit for society because sepsis is the leading cause of death worldwide.”
The drug is currently being produced through a partnership with Suzhou Yabao Pharmaceutical R&D Co., Ltd., based in China, Lawson Health Research Institute, and WorldDiscoveries. “Our long-standing partnership with Suzhou Yabao has enabled annexin A5 drug development to proceed to this point,” says Kirk Brown, Manager of Business Development, Lawson Health Research Institute. “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.”