Theravance Phase 2 Nezulcitinib Study Did Not Meet Primary Goal In Acute Lung Injury Due To COVID-19

Theravance Biopharma, Inc. (TBPH), a biopharmaceutical company primarily focused on organ-selective medicines, announced Monday that its Phase 2 study of 3 mg once-daily nezulcitinib did not meet the primary endpoint.

Nezulcitinib, also known as TD-0903, is an investigational, inhaled, lung-selective, pan-Janus kinase or JAK inhibitor in development for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

In pre-market activity on Nasdaq, Theravance shares were losing around 12 percent to trade at $15.51.

In its statement, the company announced top-line results from its Phase 2 study of 3 mg once-daily nezulcitinib compared to placebo, each in combination with standard of care.

The company noted that it was the first investigation of an inhaled JAK inhibitor in COVID-19 patients.

The study was a 1:1 randomized, double-blind, placebo-controlled, multi-center Phase 2 trial for the treatment of hospitalized COVID-19 patients with impaired oxygenation (NCT04402866). Key endpoints were measured through Day 28. Standard of care in the study included approximately 99% receiving steroids (91% received dexamethasone).

Rick Winningham, Chief Executive Officer, Theravance Biopharma, 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."

The company said Nezulcitinib demonstrated a favorable trend in improvement when compared to placebo for 28-day all-cause mortality rate. Nezulcitinib was well-tolerated when administered once-daily for up to seven days.

The company said it will share these results with FDA and other regulatory agencies to seek input on protocols to further study nezulcitinib in acute hyperinflammation in the lung.

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