COVID-19 Program

Many patients hospitalized with COVID-19 have significant lung tissue damage caused by the novel coronavirus, SARS-CoV-2.  We believe TSC’s oxygen-enhancing mechanism could potentially provide an important new treatment option for low oxygen levels and the associated risk of acute respiratory distress syndrome (“ARDS”) and multiple organ failure that can occur in COVID-19 patients.

We initiated an open-label, Phase 1b lead-in trial of TSC in hospitalised COVID-19 patients in September 2020 at the Romanian National Institute of Infectious Diseases (“NIID”) in partnership with Arensia Exploratory Medicine to evaluate the safety and tolerability of TSC in this patient population.  In addition to evaluating safety and tolerability, we will collect preliminary data on TSC’s effects on blood oxygenation, which are sometimes referred to as pharmacodynamic effects, and on certain clinical endpoints related to COVID-19 disease status.

Although the study is not powered to detect statistical differences in effect, we believe positive changes from baseline in pharmacodynamic and/or clinical efficacy data will support proof of concept for use of TSC in patients with COVID-19 who suffer from low oxygen levels.

The safety and tolerability of TSC will be evaluated in this trial at pre-set intervals by a Safety Monitoring Committee (“SMC”).

Diffusion Pharmaceuticals believes the novel mechanism of TSC could provide a supportive therapeutic benefit that has not previously been available to hospitalised COVID-19 patients and others suffering from hypoxic conditions. We are pleased to apply the technology, resources and expertise to aid in this global crisis.

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