Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib demonstrated some improvement in mortality and time to recovery.
Theravance announced its intention to develop the nebulized JAK inhibitor for the treatment of COVID-19 in April 2020 and initiated a Phase 1 trial later that month. The Phase 2 trial was initiated in June 2020.
According to the company, nezulcitinib was well tolerated at doses of 3 mg once daily, and plasma exposure for the inhaled, lung-selective drug was low, as expected. Theravance said that it intends to meet with regulatory agencies to discuss a way forward to study nezulcitinib for acute hyperinflammation of the lung.
Theravance Biopharma CEO Rick E Winningham said, “Since learning of the extensive respiratory complications in severe COVID-19, we have worked to advance the science behind inhaled lung-selective JAK inhibitors in critical diseases like COVID-19. Even though this Phase 2 study, enrolling more than 200 patients, did not meet the primary endpoint, we are encouraged by the trend in the pre-specified analysis of the 28-day mortality rate in the intent-to-treat population. We are grateful to the patients and their families, our research partners, the clinical investigators, and our team at Theravance Biopharma for their important contributions.”
Read the Theravance Biopharma press release.
