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14 June 2021
Phase III North American Clinical Trial for COVID-19 Treatment begins after FDA & Health Canada approval
An affordable decades-old drug has been reformulated and repurposed to treat COVID-19 patients.
Montreal June 14, 2021
After months of preparation, a global phase III clinical trial sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC), in partnership with Canadian start-up
Pulmonem, begins an innovative treatment to reduce and possibly prevent the development of severe pulmonary inflammation caused by the COVID-19 virus. The clinical trial will test the use of PULM-001 in patients in the early stages of COVID-19. This is one of very few phase III clinical trials for COVID therapies to obtain approval from both the U.S. Food and Drug Administration (FDA) and Health Canada.
PULM-001 is a decades-old, safe and affordable oral antibacterial that also has well-recognized anti-inflammatory properties. It has been used to treat infectious diseases such as malaria, lupus, HIV and many other inflammatory infections. The repurposed drug will be administered to symptomatic adults recovering at home to lessen lung inflammation. This inflammation causes complications in the lungs that can lead to increased hospital and ICU stays, and even death.
This Canada-led phase III clinical trial could change the course of the global pandemic, especially for developing countries that have little access to vaccines. The study will be conducted entirely remotely beginning with patients in Ontario and Quebec followed by six centres in the United States. Thousands of symptomatic (COVID-19 positive) outpatients will be involved throughout the course of the trial.
Patient recruitment is launching in Quebec and Ontario June 28: https://dapcorona.com/en/
The trial is led by Dr. Jean Bourbeau, a senior investigator and Director of the McConnell Centre of Innovative Medicine at the RI-MUHC. Dr. Bourbeau is a respirologist at the McGill University Health Centre as well as Professor and Associate Member of the Department of Epidemiology, Biostatistics and Occupational Health at McGill University.
“The vaccines are undoubtedly important, but are not the final answer to this problem. It will be a long time before the whole world is vaccinated, and until then, we need a treatment that is effective against this damaging disease. This medication is inexpensive and has a proven record of safety, and we are confident that it will prevent severe COVID-19 cases.”
– Dr. Jean Bourbeau, Director, Centre for Innovative Medicine, RI- MUHC
The trial is a collaboration between the RI-MUHC, the McGill University Health Centre (MUHC) Foundation and Pulmonem Inc., a Canadian biotech startup. Pulmonem has international manufacturing partnership agreements in place and is ready to produce the new medication for the treatment of COVID-19 quickly and in large quantities.
“I’ve been impressed to see that Canada’s clinical research expertise and infrastructure can be scaled quickly to meet the challenges of this pandemic. With the endorsement of federal health regulators in the US and Canada now in place, we can begin the trial.” says Dr. Houfar Sekhavat, President and CEO of Pulmonem Inc.
While people in Canada and other countries are being vaccinated in large numbers, affordable, safe and effective treatments for COVID-19 are still necessary. Despite continued vaccinations, cases of COVID-19 will not disappear worldwide, and many patients will still need treatment to prevent complications and hospitalizations, especially in areas of the world still coping with uncontrolled outbreaks and variants that risk coming to Canada.
The MUHC Foundation has already raised one million dollars needed to start the trial in Canada. Another $4 million is required to complete it in the United States and get cost-effective drugs to those in need.
“This collaboration between research, fundraising and private partnerships is a new and exciting way for philanthropy to play a role in changing the course of lives and medicine,” says Julie Quenneville, President and CEO of the McGill University Health Centre Foundation. “By investing early in concrete and viable treatments that can be repurposed to fight COVID-19, our supporters are truly at the forefront of transforming health care.”