Erdosteine and COVID-19 in Italy

Our colleagues at Recipharm recently completed an important study in COVID-19 patients in Milan, Italy. This study was the first to look at Health-Related Quality of Life (HRQoL) in COVID-19 patients discharged from the hospital setting.

This clinical study involved 20 patients affected by COVID-19 with severe respiratory failure, hospitalized in “L. Sacco” University Hospital in Milan (one of the major COVID-19 centers in Lombardy, the Italian region mostly affected by SARS-CoV-2). The study indicated that patients taking Erdosteine 300 mg twice daily after hospital discharge provided beneficial improvements in health-related quality of life parameters (HRQoL) and dyspnea (shortness of breath). Full results were recently published in Multidisciplinary Respiratory Medicine, the official journal of the Italian Respiratory Society. The paper is titled “Changes in quality of life and dyspnea after hospitalization in COVID-19 patients discharged at home” (Santus P., Tursi F., Croce G., Di Simone C., Frassanito F., Gaboradi P., Airoldi A., Pecis M., Negretto G., Radovanovic D.).

This information on Erdosteine in Italy is provided as a courtesy to investors only as an Investor Relations communication. Alitair may or may not pursue COVID-19 development work in the US. Erdosteine is not FDA approved for treating COVID-19 patients , or any patients in the United States and is not available in the US market. Alitair is not making any assertation of the safety or effectiveness of Erdosteine in any patient type and will not do so until FDA approves the product based on our clinical development program and NDA filing.

Alitair holds an open IND for Erdosteine and has received Orphan Drug designation for treating bronchiectasis. Once fully funded, Alitair intends to begin Phase II studied in non-CF bronchiectasis patients in the US. Future development in CF-bronchiectasis patients, COVID-19, and other indications will be fully explored; however, these are not focus areas today.

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