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Inhaled JAK inhibitor GDC-0214 reduces exhaled nitric oxide in patients with mild asthma: A randomized, controlled,

Irene E Braithwaite1, Fang Cai2, Jennifer A Tom2

  • 1Medical Research Institute of New Zealand, Wellington, New Zealand.

The Journal of Allergy and Clinical Immunology
|March 21, 2021
PubMed
Summary

Inhaled GDC-0214, a Janus kinase (JAK) inhibitor, significantly reduced airway inflammation biomarker fractional exhaled nitric oxide (Feno) in mild asthma patients. The treatment was well-tolerated, showing no systemic toxicity.

Keywords:
JAK inhibitorairway inflammationclinical trial

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Area of Science:

  • Pharmacology
  • Respiratory Medicine
  • Immunology

Background:

  • The Janus kinase (JAK) pathway is crucial for mediating cytokine activity, including IL-4 and IL-13, which are implicated in asthma pathogenesis.
  • GDC-0214 is an investigational, inhaled, small-molecule inhibitor targeting the JAK pathway, specifically developed for asthma treatment.

Purpose of the Study:

  • To evaluate the efficacy of GDC-0214 in reducing fractional exhaled nitric oxide (Feno), a biomarker of airway inflammation, in adults with mild asthma.
  • To assess the safety and tolerability of inhaled GDC-0214 in this patient population.

Main Methods:

  • A double-blind, randomized, placebo-controlled, phase 1 study was conducted in adults with mild asthma and elevated Feno levels.
  • Participants received ascending doses of GDC-0214 or placebo for 10 days after a 4-day placebo run-in period.
  • The primary endpoint was the placebo-corrected percentage reduction in Feno from baseline to day 14, with pharmacokinetic and safety assessments also performed.

Main Results:

  • GDC-0214 demonstrated a dose-dependent reduction in Feno, with a placebo-corrected reduction of -23% at 15 mg once daily and -42% at 15 mg twice daily at day 14.
  • Higher plasma exposure to GDC-0214 correlated with greater Feno reduction.
  • The drug was well-tolerated, with no dose-limiting adverse events, serious adverse events, or evidence of systemic JAK inhibition.

Conclusions:

  • Inhaled GDC-0214 effectively reduces airway inflammation, as indicated by Feno levels, in patients with mild asthma.
  • The compound shows a favorable safety profile, with no significant systemic toxicity observed, supporting its potential as an asthma therapy.