Intranasal ETH47 in asthma following rhinovirus challenge
Research type
Research Study
Full title
A Phase IIa, double-blind, randomized, placebo-controlled trial in participants with asthma to evaluate the impact of intranasal ETH47 on the development of lower respiratory tract symptoms following rhinovirus challenge
IRAS ID
1011224
Contact name
Michael Edwards
Contact email
Sponsor organisation
Ethris GmbH
ISRCTN Number
ISRCTN21576805
Research summary
This trial will assess the efficacy of intranasal ETH47, a drug candidate for preventing asthma exacerbations triggered by respiratory virus infections. ETH47 is an mRNA-based drug that encodes human interferon-lambda 1 (interleukin-29), a cytokine that defends against viral infections.\n\nAsthma exacerbations, primarily caused by respiratory viral infections such as rhinoviruses (RVs), contribute significantly to asthma-related morbidity and mortality. There are no antiviral treatments for RVs, and preventive vaccines are limited. Evidence suggests that using antiviral treatments proactively could reduce viral infection severity and prevent asthma exacerbations, thereby preserving lung function.\n\nThe trial will test ETH47’s effectiveness in preventing asthma exacerbations induced by rhinovirus in people with asthma. Participants will be screened to ensure they meet the trial criteria. Those with antibodies to the test virus (sero-positive) will be excluded. Only sero-negative asthmatic individuals will be eligible. The trial will last up to 9 weeks and involve 16 clinical visits.\n\nBefore infection, participants will be randomized to receive either ETH47 or a placebo, with the treatment given the day before infection (Day -1). Lung function will be assessed using methacholine testing, alongside allergy skin tests and chest X-rays to confirm asthma.\n\nThroughout the trial, participants will provide various samples, including blood, nasal secretions, nasal washes, sputum, and breath samples, to measure ETH47 levels and immune responses to rhinovirus infection. Clinical symptom scores and lung function will also be monitored to assess the impact of ETH47 on asthma symptoms and lung health.\n\nThe trial will analyse the data to determine whether ETH47 can reduce the severity of asthma exacerbations and improve clinical outcomes in individuals with asthma.
REC name
Wales REC 3
REC reference
25/WA/0013
Date of REC Opinion
14 Feb 2025
REC opinion
Further Information Favourable Opinion