FDAnews
www.fdanews.com/articles/200907-synairgen-begins-dosing-in-phase-3-trial-of-inhaled-covid-19-treatment

Synairgen Begins Dosing in Phase 3 Trial of Inhaled COVID-19 Treatment

January 15, 2021

UK drugmaker Synairgen has dosed the first patient in a global phase 3 trial evaluating an inhaled formulation of interferon beta-1a, SNG001, for treating hospitalized COVID-19 patients who require supplemental oxygen.

Synairgen has identified several UK sites and plans to enroll volunteers at clinics in the EU and U.S., where the FDA has granted SNG001 Fast-Track status. Waltham, Mass.-based Parexel Biotech will help conduct the trial.

The phase 3 study of SNG001 will eventually cover an estimated 20 countries and is expected to enroll 610 COVID-19 patients requiring mechanical ventilation. The UK drugmaker is also running a phase 2 trial of nonhospitalized COVID-19 patients.

Interferon beta-1a is used as an injectable treatment for multiple sclerosis, but Synairgen had been developing its inhaled version as a treatment for asthma and chronic obstructive pulmonary disease.

“Development of treatments like ours will remain necessary in cases where vaccines are not effective, for those who do not get vaccinated and in case the virus mutates to the point where vaccines become less effective,” said Synairgen CEO Richard Marsden.

In other news from a late-stage study of a COVID-19 treatment, Alexion Pharmaceuticals halted enrollment for its global phase 3 trial evaluating Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 who require mechanical ventilation, after the drug failed to show efficacy when added to best supportive care. ― Jason Scott