SPOKANE, Wash. – Pulmonem Inc, and the Research Institute of the McGill University Health Centre announced they will begin Phase 3 of their clinical trial of their therapeutic drug PULM-001, recruiting patients in Washington, Idaho, and North Carolina.
PULM-001 is a reformulated version of the existed FDA approved anti-inflammatory drug Dapsone. Traditionally, Daspone has been used as both an antibacterial and anti-inflammatory treatment for leprosy, malaria, HIV, lupus, and pneumocystis pneumonia. In patients with COVID-19, it was used in a small clinical trial to prevent and treat acute respiratory distress syndrome (ARDS), reducing mortality from 40% to 0% in the study.
Dr Houfar Sekhavat, founder and interim CEO and Chairman of Pulmonem Inc. expressed hopefulness for the drugs efficacy. In a press release, he stated, “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.”
The trial itself will have a roster of 3,000 participants over the age of 40 who have been confirmed to have symptomatic COVID-19 who are not hospitalized or otherwise described in the exclusion criteria. Participants will be randomly assigned either 85 mg of Dapsone or 85 mg of a placebo to take twice daily for 21 days. A follow-up after 7 days to assess the outcome and need for continued monitoring will be conducted.
To learn more about the study, you or your doctor can contact Sharmistha Biswas or Maria F Sedeño be e-mail, or by the numbers listed in the trial overview.
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.
