Phase 2a Study in Healthy Adult Participants Pre treated with INNA-051 and Challenged with Influenza
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Prophylactic Efficacy, Safety and Tolerability of INNA-051 in Healthy Adult Participants Challenged with Influenza A/Perth/16/2009 (H3N2) Virus
IRAS ID
1004506
Contact name
Nicole Kruger
Contact email
Sponsor organisation
ENA Respiratory Pty Ltd
Eudract number
2021-005701-27
Clinicaltrials.gov Identifier
Research summary
Research Summary
The purpose of this study is to investigate experimental treatment INNA-051 for influenza infection caused by influenza viruses. Up to123 healthy volunteers 18-55 years of age who consent to the participation in this research will be invited to a Quarantine unit at hVIVO, to stay for approximately 14 days. Participants will be randomly allocated to one of three treatment groups (41 participants per group), to receive either 1 of 2 pre-treatment doses of INNA-051 or placebo via a nasal spray. The INNA-051 and placebo will be administered in a blinded manner which means participants, research staff and sponsor will not know which participants received INNA-051 or placebo. To test the study drug, healthy participants will be infected (inoculated) with a flu virus, which is called Influenza A/Perth/16/2009 (H3N2) the day after their second dose of study drug or placebo. After completion of the Quarantine phase, participants will need to return for a final follow up visit approximately 28 days (±3days) from the date they receive the Influenza virus.
Summary of Results
A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Prophylactic Efficacy, Safety and Tolerability of INNA-051 in Healthy Adult Participants Challenged with Influenza A/Perth/16/2009 (H3N2) Virus. This study was carried out by hVIVO Services Ltd. in London, United Kingdom on behalf of the study Sponsor ENA Respiratory Pty Ltd. INNA-051 is being developed as an immune modulator for the prevention of complications associated with different respiratory viral infections in the at-risk populations. The purpose of this research was to test if an experimental drug called INNA-051 (the ‘study drug’) may help in combating a strain of the Influenza virus (the ‘study virus’) by activating the immune response before people become infected. Influenza is an infectious disease commonly referred to as ‘the flu’. The Influenza virus can spread easily through the air, often by coughs and sneezes, and can cause mild to severe illness. The symptoms of influenza illness can be confused with the common cold, but that is caused by a different virus and the symptoms are usually milder than the flu.
123 participants were randomly (by chance) allocated to one of three treatment groups with 41 participants in each group. After admission to the clinical unit, the first dosing with study drug occurred the following day and the second dosing occurred 3 days later. Participants were assigned by chance to one of the three groups: Group 1: Placebo; once a day on each dosing day (41 participants); Group 2: 150 µg (micrograms) of INNA-051 on each dosing day (39 participants); Group 3: 300µg (micrograms) of INNA-051 on each dosing day (41 participants). Participants were given the study virus the day after they have been given the second dose of Study Drug and were monitored in the quarantine until discharge on Day 8.
Four participants (1 in the placebo arm and 3 in the INNA-051 150 µg arm) discontinued the study due to treatment-emergent adverse events (TEAEs). Two TEAEs (oropharyngeal pain and cough both mild and possibly related to study treatment reported by 1 participant) in the placebo arm and 11 TEAEs (rhinorrhoea, nasal congestion, oropharyngeal pain, and headache, all mild and possibly related to study treatment reported by 1 participant; nasal congestion, sneezing, oropharyngeal pain, fatigue, malaise, headache, and pyrexia, all mild and unlikely related to study treatment reported by 1 participant) in the INNA-051 150 µg arm, led to study discontinuation prior to viral challenge. One TEAE of tonsillitis, moderate in severity, and not related to the study treatment, reported by 1 participant in the INNA-051 150 µg arm, led to study discontinuation after viral challenge.
Regarding safety, the 2-dose regimen of INNA-051 and subsequent challenge virus administration with influenza A/Perth/16/2009 (H3N2) were safe and well tolerated. No antiviral effect of INNA-051 in the influenza A/Perth/16/2009 (H3N2) model was demonstrated as per the chosen endpoints. The virology and clinical symptom scores efficacy endpoints did not demonstrate a significant effect. Notably, the viral inoculum was expected to result in a majority of participants being infected. Interpretation of the study was complicated by lower than anticipated rate of infection in the placebo arm and an unexpectedly large proportion of participants having pre-existing immunity to the challenge influenza virus strain across all groups (assessed using the hemagglutination inhibition assay). Post hoc analyses excluding those with pre-existing immunity showed that INNA-051-treated participants with PCR laboratory-confirmed infection had a statistically significant shorter duration of infection and evidence of elevated biomarkers of immune response activation. This effect was greater with the higher INNA-051 dose.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0272
Date of REC Opinion
24 Jan 2022
REC opinion
Further Information Favourable Opinion