Benzinga | Jun 21, 2021 07:37AM EDT

Theravance Biopharma Stock Drops After Nezulcitinib Disappoints In COVID-19 Study

* 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.