Theravance Biopharma Inc (NASDAQ: TBPH) has announced top-line results from its Phase 2 study evaluating nezulcitinib for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.
Nezulcitinib is an investigational, inhaled, lung-selective, pan-Janus kinase (JAK) inhibitor.
No statistically significant difference in Respiratory Failure-Free Days (RFDs) from randomization through Day 28 between nezulcitinib and placebo was reported.
Nezulcitinib demonstrated a favorable trend in improvement when compared to placebo for 28-day all-cause mortality (total number of deaths: 6 vs. 13) and time to recovery (median: 10 vs. 11 days).
In patients with CRP of more than 150 mg/L (n=171), there was an improvement in those treated with nezulcitinib compared to placebo.
28-day all-cause mortality (total number of deaths: 1 vs. 9) and time to recovery (median: 10 vs. 11 days).
In patients with CRP >150 mg/L (n=30), there was no difference in time to recovery or 28-day all-cause mortality between those treated with nezulcitinib or placebo.
Nezulcitinib was well-tolerated; adverse events and serious adverse events occurred in 34.0% and 9.7% of patients treated with nezulcitinib, 41.2%, and 15.7% treated with placebo, respectively.
Adverse events of liver abnormalities or disease occurred in 9.7% and 7.8% of patients treated with nezulcitinib and placebo, respectively.
Severe infections and venous thromboembolism occurred in 1.0% and none of the patients treated with nezulcitinib, and 2.0% and 4.9% in patients treated with placebo, respectively.
The Company will share these results with FDA and other regulatory agencies to seek input on protocols further to study nezulcitinib in acute hyper inflammation in the lung.
The Company will hold a conference call today at 8 am E.T.
Price Action: TBPH shares are down 6.39% at $16.40 during the premarket session on the last check Monday.
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