Pulmonem Inc., a Canadian biotech start-up, is pleased to announce Health Canada approval of the Phase III Randomized Clinical Trial of an oral medication developed by the company as an early treatment to reduce or even prevent the development of severe pulmonary inflammation caused by COVID-19 infection, preventing the excessive immune reaction that is the most frequent cause of worsening symptoms and complications which lead to hospital admissions, ICU stays, and fatalities. The Phase III Clinical Trial is sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC) and will be conducted in seven centres in Canada and the United States as soon as the necessary funding has been secured.

COVID-19 has already infected over 24M and killed more than 800,000 people around the world. Measures to prevent its propagation have severely disrupted the global economy. Research into vaccines is underway in many countries around the globe; but, even with accelerated efforts, new vaccines are time consuming and costly to develop. Moreover, experts are divided about the likelihood that  a vaccine will generate an effective or sustainable immune response. Meanwhile, with the arrival of fall and back to school, Canada and other countries are bracing for a second wave. By neutralizing the aspect of COVID-19 that causes the gravest complications and fatalities, Pulmonem’s medication could support a return to more normal life and economic activity, while the world awaits an effective vaccine.

The therapy developed by Pulmonem is unique in that it is a patented reformulation of Dapsone, a safe and affordable generic anti-inflammatory, immuno-modulator and anti-bacterial drug that has been around for decades, used against malaria, lupus, HIV and other inflammatory infections.  Because the new medication is a reformulation of an existing drug for a new indication, this therapy could be available on a much-accelerated timeline compared to others in development. It could be ready to be administered to Canadians before the end of 2020.

Dr. Barbeau

“While aggressive mitigation strategies are being implemented to slow the spread of coronavirus 2 (SARS-CoV-2), we quickly turned to develop and implement scientifically sound drug candidates using high-quality randomized controlled trials. Immunomodulatory agents used to attenuate COVID-19-associated cytokine storm such as Dapsone, could turn out to be a most significant advancement in COVID-19 therapeutics. With no proven effective treatments for outpatient COVID-19 and to prevent complications such as hospital admissions, showing that Dapsone has a net clinical benefit should be a public health priority.” – Dr. Jean Bourbeau, Principal investigator of the Research Institute McGill University Health Centre.

With the approval by Health Canada and domestic and international research ethics board approvals in place, RI-MUHC is poised to begin the Phase III Clinical trial as soon as sufficient funding is secured. Recognizing the promise and importance of the new drug therapy, as well as the need for swift action to save lives, the McGill University Health Centre Foundation has committed to help raise funds to support the Clinical Trial. Pulmonem is looking for additional public and private investment.

“Our foundation is determined to help the scientific community find a cure for COVID-19 and end this pandemic,” says Julie Quenneville, President of the McGill University Health Centre Foundation. “Studying the efficacy of Dapsone on patients with severe respiratory distress syndrome caused by COVID-19 is an important step in saving lives in Canada and around the world”

The Phase III Randomized Clinical Trial of Pulmonem’s early treatment approach will be conducted as a an investigator-initiated clinical trial being 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. Dr. Bourbeau and his team’s extensive expertise in clinical trials will guide the international team investigating the severe inflammatory events triggered by COVID-19 and how these can be mitigated.

The Phase III Randomized Clinical Trial will be conducted with over 2000 patients and is slated to begin during September in Canada, and towards the end of September or in early October in the United States. The clinical trial itself is ground-breaking: Canada is leading very few Phase III Clinical Trials for the treatment of COVID-19.

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.

Pulmonem’s drug therapy is the brainchild of Dr. Houfar Sekhavat, a New Brunswick-based ophthalmologist and entrepreneur.

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