Pulmonem Inc. was founded to demonstrate the effectiveness and safety of a reformulated and patented version of Dapsone, a 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 and liquids.
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Pulmonem is developing and testing a therapy to treat COVID-19 with a newly patented oral medication to arrest the development of inflammation caused by COVID-19 infection, preventing the excessive immune reaction that is the most frequent cause of worsening symptoms and complications requiring hospitalization.
COVID-19 has already affected more than 24 million people around the world and severely disrupted the global economy. By neutralizing the aspect of COVID-19 that causes the gravest complications and fatalities, Pulmonem’s medication could allow for a return to “normal life”, while the world awaits a vaccine.
The therapy developed by Pulmonem is unique in that it is a reformulation of Dapsone, a safe and affordable generic anti-inflammatory drug that has been around for decades, used to treat 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.
Pulmonem has manufacturing partnership agreements in place and is ready to start producing its new medication for the treatment of COVID-19 quickly and in large quantities. Manufacturing is set to take place in New Brunswick and in the U.S. for immediate worldwide distribution upon the successful completion of the trial and regulatory approvals.
Pulmonem’s medication could be ready to be administered to Canadians before the end of 2020.
DAP-CORONA Clinical Trial
Pulmonem will be the first company to investigate the use of a reformulated and patented version of Dapsone as a treatment for COVID-19. The Company will test an early treatment approach to arresting COVID-19 complications among non-hospitalized, confirmed cases during its DAP-CORONA Phase 3 Clinical Trial.
The Phase 3 Clinical Trial is sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC).
DAP-CORONA is a randomized, triple-blind, placebo-controlled, parallel, multicentre trial to evaluate the efficacy and safety of the reformulated and patented version of Dapsone in older adults (70+ years of age) and/or in adult patients (40+ years of age) with at least one high-risk comorbidity, with confirmed COVID-19 infection.
The trial will comprise a total of 2,100 infected patients diagnosed with COVID-19, non-hospitalized at the time of enrolment and meeting all inclusion and no exclusion criteria. They will be randomized to receive either reformulated and patented version of Dapsone tablets or placebo tablets for 21 days and will be followed up for 30 days after termination of treatment.
The Advantages of Our Solution
- We believe that our therapy will alleviate and may even prevent the pulmonary inflammatory phase of COVID-19, helping prevent the hospitalization of those who become infected.
- The generic drug we are testing has been successfully used as an anti-inflammatory and has been used to treat other infectious diseases, including malaria, lupus, HIV and pneumocystis jirovecii pneumonia.
- is based on a generic and thus affordable.
- is efficiently absorbed (70% to 80%) via the gastrointestinal tract and is therefore suitable for outpatient settings.
- reaches peak serum concentration in 2 to 6 hours and has a half-life of 20 to 30 hours.
- is well distributed to the fluid of the alveolar spaces in the lung.
- has well-documented metabolic, pharmacokinetic and toxicological profiles.
Houfar Sekhavat, MD
Founder, President and CEO
Ophthalmologist, serial entrepreneur and innovator. Founder of Triple Hair Inc. (hair growth therapies) and Hexiris Pharma Inc. (treatment of glaucoma).
Jean-Philippe Gravel, MBA
Co-Founder and Chief Operating Officer
Over 15 years of experience in management and business development, mainly with medical, pharmaceutical and natural health product companies. President and CEO of Triple Hair Inc.
Bruno Battistini, B.Sc., M.Sc., Ph.D.-Pharmacology
Co-Founder, Chief Clinical and Government Affairs Officer
Accomplished health care researcher, former professor of medicine, entrepreneur, senior executive and administrator whose background in pharmacology has resulted in a broad range of experience working with universities, government agencies and health foundations.
Denis Albert, CPA, CA
Managing partner at Boudreau Albert Savoie & Associates, in charge of operations, strategic direction and client relationships, with over 21 years of experience in accounting, tax planning and business-related matters, including tax and financial restructuring, financing, business sales and acquisitions.
Awdah Arraf, Ph.D.
Patent and innovation strategy specialist with over 20 years of experience helping tech and pharma start-ups establish and exploit patent portfolios. Engaged in science and technology, she dedicates her skills to organizations with profound products and services that will ultimately contribute to enhancing the lifestyle and wellbeing of individuals globally.
Erika Tremblay-Gagnon, CPA CA, M.Sc.
Chief Financial Officer
Over 14 years of financial executive experience, mainly as VP, Corporate Finance with TSX-listed Stingray Group and Senior Manager, Audit and Certification at PricewaterhouseCoopers.
Satish Asotra, Ph.D., MBA
Chief Manufacturing and Regulatory Officer
Senior executive and strategic leader with a proven track record of driving pharmaceutical development, innovation and process improvement with 25 years of experience, including more than 12 years in topical and dermatological product development, with Avicanna, AHI, Accucaps, Odan Laboratories and Taro Pharmaceuticals.
Attila Hajdu, M.Sc., MBA
Chief Business Officer
Accomplished leader with over 20 years of experience years in the global pharmaceutical and biotechnology industry, mainly in business development, sales, marketing, finance and medical affairs with GlaxoSmithKline, Astellas, Sirona Biochem, and Stelvio Therapeutics.
Georges H. Lavanchy
Vice President, International Development
Entrepreneur with international management experience in various fields for over 30 years. Excellent knowledge of European markets and their business practices. Searching for innovative products to be developed.
Avraham Yacobi, Ph.D., M.Pharm.
Principal Scientific Advisor
Expert consultant with over 35 years of experience in pharmaceutical R&D and regulatory affairs. Previously served as President of R&D at Taro Pharmaceuticals USA for 16 years, and as Senior VP and Officer at Taro Pharmaceutical Industries. Currently President of DOLE Pharma, LLC and Founder and Scientific Advisor to BluPax Pharma.
Dr. Jean Bourbeau
Professor (Medicine), McGill University; Respirologist, MUHC; GSK-CIHR Research Chair and Director, Centre for Innovative Medicine, RI-MUHC.
Dr. Bryan Ross
Quebec Site Investigator
Assistant Professor (Medicine), Respirologist, MUHC, McGill University.
Dr. Sharmistha Biswas
PhD (c) Experimental Medicine-Epidemiology, RI-MUHC, McGill University.
Dr. Andrea Benedetti
Associate Professor (Medicine; Epidemiology & Biostatistics) McGill University; Scientist, RI-MUHC.
Other Sites in Canada
Dr. Gerard Criner
Co-Principal Investigator, Pennsylvania Site
Professor and Chair (Thoracic Medicine and Surgery), Temple University; Director, Temple Lung Center.
Dr. Omar Gonzalez
Arizona Site Investigator
Director (Infection Control), Dignity Health St. Joseph’s Hospital and Medical Center.
Dr. Richard Sue
Arizona Site Sub-Investigator
Respirologist and Intensivist, Dignity Health St. Joseph’s Hospital and Medical Center.
Dr. Janine Vintch
California Site Sub-Investigator
Professor (Medicine), David Geffen School of Medicine, UCLA.
Dr. Fortune Alabi
Central Florida Site Investigator
Respirologist and Intensivist, Florida Lung, Asthma & Sleep Specialists.
Dr. Shirin Shafazand
Miami Site Investigator
Professor (Medicine), Miller School of Medicine, University of Miami.