Theravance Biopharma (TBPH) Announces Top-Line Phase 2 Data of Nezulcitinib In COVID-19 Patients Hospitalized With Acute Lung Injury

June 21, 2021 6:11 AM EDT

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Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today 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. Nezulcitinib is an investigational, inhaled, lung-selective, pan-Janus kinase (JAK) inhibitor in development for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

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

"This is the first investigation of an inhaled JAK inhibitor in COVID-19 patients. The classification of a COVID-ALI endotype using a blood biomarker, such as C-reactive protein, may advance the understanding and stratification of a subpopulation of patients with immune characteristics that best responds to a targeted-therapeutic such as nezulcitinib," said John Belperio, MD, professor of medicine in the pulmonary and critical care department at the David Geffen School of Medicine at UCLA and trial investigator.

The study was a 1:1 randomized, double-blind, placebo-controlled, multi-center Phase 2 trial for the treatment of hospitalized COVID-19 patients (n=210) 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).

Key Study Findings

  • Outcomes:
    • Primary: No statistically significant difference in RFDs from randomization through Day 28 between nezulcitinib and placebo in ITT (median: 21 vs. 21 days; p=0.61).
    • Secondary: No difference in change from baseline at Day 7 in SaO2/FiO2 ratio, proportion of patients in each category of the 8-point Clinical Status scale, and proportion of patients alive and respiratory failure-free at Day 28.
    • Nezulcitinib demonstrated a favorable trend in improvement when compared to placebo for 28-day all-cause mortality (total number of deaths: 6 vs. 13, HR: 0.42, p=0.08) and time to recovery (median: 10 vs. 11 days, HR: 1.27, p=0.12).
    • In a post-hoc analysis of patients with baseline CRP (n=201):
      • In patients with CRP <150 mg/L (n=171), there was an improvement in those treated with nezulcitinib when compared to placebo in:
        • 28-day all-cause mortality (total number of deaths: 1 vs 9, HR: 0.097, p=0.009).
        • time to recovery (median: 10 vs. 11 days, HR: 1.48, p=0.02).
      • 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.
  • Safety:
    • Nezulcitinib was well-tolerated; adverse events and serious adverse events occurred in 34.0% and 9.7% of patients treated with nezulcitinib, and 41.2% and 15.7% of patients 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.
    • Serious 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.
  • Plasma exposure of nezulcitinib was low and consistent with expectations for a lung-selective medicine.

The Company 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. A more detailed analysis of the data, including further pharmacokinetic and biomarker results, will be available in the future.

Conference Call and Live Webcast Today at 8 am ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 8 am ET / 5 am PT / 1 pm IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 6984147. Those interested in listening to the conference call live via the internet may do so by visiting, under the Investors section, Events and Presentations.

A replay will be available on for 30 days through July 21, 2021. An audio replay will also be available through 11:00 am ET on June 28, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 6984147.

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