Efficacy and Safety of Nemiralisib in Patients with Acute Exacerbation of COPD

Pavankumar Kamat


June 16, 2021


  • In patients with moderate or severe acute exacerbation of chronic obstructive pulmonary disorder (COPD), the addition of nemiralisib to standard-of-care treatment for 12 weeks did not improve lung function compared with placebo.

  • Furthermore, nemiralisib had no effects on the rate of re-exacerbation, recovery from the index exacerbation or patient health status associated with exacerbation recovery.

Why this matters

  • Patients with acute exacerbations of COPD often have an unmet treatment need. 

Study design

  • A multicentre, double-blind, placebo-controlled study of 938 patients with COPD who were randomly assigned to receive placebo (n=276) or nemiralisib 12.5 μg (n=22), 50 μg (n=91), 100 μg (n=92), 250 μg (n=90), 500 μg (n=89) or 750 μg (n=278; ratio of 3:1:1:1:1:1:3) for 12 weeks with an exploratory 12-week follow-up period.

  • Primary outcome: change in post-bronchodilator forced expiratory volume in 1 second (FEV1) at 12 weeks.

  • Funding: GlaxoSmithKline.

Key results

  • No difference was seen in the change from baseline FEV1 at week 12 between the nemiralisib 750 μg and placebo groups (posterior adjusted median difference, −0.004L; 95% credible interval, −0.051L to 0.042L).

  • Overall, no differences were seen in exacerbation rates, Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-defined recovery at 28 days and in the time to EXACT-defined recovery, COPD Assessment Test and St George's Respiratory Questionnaire for COPD between the nemiralisib and placebo groups.

  • The most common adverse event was cough, with a higher incidence reported in the nemiralisib 500 μg (35%) and 750 μg (35%) groups than in the placebo group (5%).


  • Procalcitonin has been identified as a potential marker of bacterial exacerbations of COPD, though its ability to discriminate may be moderate.


Fahy WA, Homayoun-Valiani F, Cahn A, Robertson J, Templeton A, Meeraus WH, Wilson R, Lowings M, Marotti M, West SL, Tabberer M, Hessel EM. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study. Int J Chron Obstruct Pulmon Dis. 2021;16:1637-1646. doi: 10.2147/COPD.S309320. PMID: 34113095.  View full text

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.


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