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November 23, 2021

Pulmonem initiates US subject recruitment in Phase III Covid-19 drug trial

The trial of PULM-001 is expected to be conducted in North Carolina, Washington and Idaho in the US.

Pulmonem and the Research Institute of the McGill University Health Centre have commenced US-based subject enrolment in the Phase III clinical trial of the drug, PULM-001, for Covid-19.

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A repurposed and reformulated form of an already approved anti-inflammatory therapy, Dapsone, by the Food and Drug Administration (FDA) and Health Canada, PULM-001 demonstrated to avert and treat acute respiratory distress syndrome linked to Covid-19 in a randomised trial.

Furthermore, treatment with PULM-001 lowered the death to 0% from 40% in the trial.

Pulmonem noted that earlier the drug was used for the treatment of infectious diseases, including lupus, malaria, pneumocystis pneumonia and human immunodeficiency virus.

Sponsored by Peters Medical Research and Principal Research Solutions, the Phase III trial is planned to be carried out in North Carolina, Washington and Idaho in the US.

The company expects to receive $6 to $8m in funding by early next year to conclude the trial.

The McGill University Health Centre Foundation is a key financial partner and presently the programme’s key investor.

On concluding the trial, Pulmonem hopes that PULM-001 could be purchased by various governments and supplied using its government networks.

The company signed an agreement with a US-based supplier, which can potentially manufacture one billion PULM-001 tablets on a monthly basis.

Pulmonem founder, interim CEO and chairman Dr Houfar Sekhavat said: “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.”

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Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
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