Promising COVID-19 Therapeutic Drug to start Phase 3 Clinical Trial in the United States
DIEPPE, New Brunswick, Nov. 22, 2021 (GLOBE NEWSWIRE) — Pulmonem Inc. and the Research Institute of the McGill University Health Centre today announced that they have successfully started recruiting US-based patients for the Phase 3 Clinical Trial (ClinicalTrials.gov Identifier: NCT04935476) of the promising COVID-19 therapeutic drug PULM-001.
PULM-001 is a repurposed and reformulated version of an existing FDA and Health Canada approved anti-inflammatory drug (Dapsone) that has been shown to prevent and treat acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection and reduce mortality from 40% to 0% in a small, randomized clinical trial. The drug was previously used to treat infectious diseases, including malaria, lupus, Human Immunodeficiency Virus (HIV) and pneumocystis pneumonia.
Upon successful completion of the Phase 3 Clinical Trial, PULM-001 could be procured by governments and distributed through existing, well-established government networks. Pulmonem has an agreement in place with a US-based supplier that has the capability to produce one billion tablets per month of PULM-001.
The Phase 3 Clinical Trial will take place in North Carolina, Washington and Idaho under the sponsorship of Peters Medical Research and Principal Research Solutions.
The McGill University Health Centre Foundation is a major financial partner and current lead investor in the project. Pulmonem anticipates a US$6 to $8 million financing will be required by early 2022 to complete the Phase 3 Clinical Trial.
Pulmonem plans to initiate steps to list its shares in Canada and Germany in the first half of 2022, by way of a reverse takeover, direct listing or other going public transaction. Any such transaction will be subject to applicable regulatory approvals and to Pulmonem fulfilling all of the listing requirements of the applicable exchanges. There can be no assurance that any such transaction will be completed.
“Pulmonem is the first company to investigate the use of PULM-001 as a treatment for COVID-19. With PULM-001’s ability to treat and prevent acute respiratory distress syndrome at both the brainstem level and in lung tissue, we are highly-optimistic for the drug’s potential as a therapeutic for COVID-19.”
– Dr. Houfar Sekhavat, founder, interim CEO and Chairman of Pulmonem Inc.
“The potential of PULM-001 is exciting and important. Here is a therapy, based on a safe and very affordable existing drug, that could save vulnerable lives, prevent the overwhelming of healthcare capacities and resources, and provide viable support for a safe return to normal activity.”
– Dr. Jean Bourbeau, Senior Investigator and Director, McConnell Centre of Innovative Medicine, Research Institute of McGill University Health Centre; Respirologist, McGill University Health Centre; Professor of Medicine, Epidemiology and Biostatistics, McGill University
Pulmonem Inc. is a clinical-stage biotechnology company specializing in the development, manufacturing and commercialization of COVID-19 therapeutics. The company was founded to demonstrate the effectiveness and safety of PULM-001, a patented and reformulated generic drug, to arrest the development of inflammation caused by COVID-19 and help prevent hospitalization of those who become infected. Pulmonem has established manufacturing partnerships that will allow the company to quickly bring this treatment to market soon after successful completion of clinical trials.
Pulmonem is also pursuing solutions for the pediatric market, as well as alternative delivery systems, such as Nasal sprays, inhalers and liquids.
ABOUT THE RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and healthcare research centre. The Institute, which is affiliated with the Faculty of Medicine of McGill University, is the research arm of the McGill University Health Centre (MUHC) – an academic health centre located in Montreal, Canada, that has a mandate to focus on complex care within its community. The RI-MUHC supports over 420 researchers and close to 1,200 research trainees devoted to a broad spectrum of fundamental, clinical and health outcomes research at the Glen and the Montreal General Hospital sites of the MUHC. Its research facilities offer a dynamic multidisciplinary environment that fosters collaboration and leverages discovery aimed at improving the health of individual patients across their lifespan. The RI-MUHC is supported in part by the Fonds de recherche du Québec – Santé (FRQS).