SOUTHAMPTON, UK I October 12, 2016 I Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, announced today that it has received the following INEXAS clinical trial update from AstraZeneca (AZ) relating to AZD9412, inhaled interferon beta, a programme developed by Synairgen and licensed to AZ in June 2014.
INEXAS clinical trial update from AstraZeneca:
“AstraZeneca has decided to stop the Phase IIa trial for AZD9412 based on an interim analysis, where an overall very low number of reported severe exacerbations could make primary endpoint conclusions difficult.
“The interim analysis confirmed the positive safety and tolerability profile seen in previous trials, and inhaled IFN-b remains an interesting treatment opportunity for patients with respiratory disease. AstraZeneca will now review the data and study design before deciding on the best way forward for the programme.”
AstraZeneca will evaluate the key data collected from the INEXAS trial with a focus on the secondary endpoints that are most predictive of disease worsening to exacerbation, and Synairgen has been informed that there will be sufficient numbers of patients in the trial to assess this. Full results are expected in Q1 2017.
Professor Stephen Holgate CBE said: “New treatments to prevent severe exacerbations are needed and most exacerbations are caused by the common cold and flu. Unexpectedly, colds did not cause as many asthma exacerbations as were predicted in this clinical trial population. We hope to learn from the results of this trial which population within severe asthma, or other respiratory diseases, will most benefit from AZD9412 and should be included in future trials.”
Richard Marsden, Synairgen’s Chief Executive Officer, said: “Although the exacerbation rate in the entire population to date has been lower than we expected based on the assumptions behind the trial design, we look forward to reviewing the other clinically important qualitative and quantitative measures of the potential effectiveness of AZD9412, building on the experience of our previous trial outcomes in this section of the asthmatic population.”
Background to the INEXAS trial:
In the trial, named INEXAS (details available on www.clinicaltrials.gov), asthma patients were dosed with placebo or AZD9412 at the onset of common cold symptoms. Previous research has shown that common colds can cause severe exacerbations of asthma and that boosting the antiviral defences of the lung with AZD9412 (inhaled interferon beta, an antiviral protein) during this time could prevent exacerbations from developing.
The INEXAS trial design:
The target number of patients recruited into any clinical trial is based on assumptions about the number of events and the anticipated benefit of the drug. In the INEXAS trial there have been far fewer exacerbations (“events”) than anticipated possibly due to patient selection and environmental/regional factors, and therefore the trial’s primary outcome could be hard to conclude within its current design.
Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on asthma and COPD, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. Leveraging its scientific and clinical facilities at Southampton General Hospital, the Company uses in vitro and ex vivo models to progress opportunities into clinical development. The BioBank of human samples is used in these models to increase confidence in the likelihood of successful drug development. Core to Synairgen’s business strategy is the realisation of value via licensing transactions. This approach has been validated by the licensing agreement formed with AstraZeneca in June 2014 for Synairgen’s SNG001 (AZD9412) programme in asthma/COPD. In August 2015 the Company entered into a collaboration with Pharmaxis to develop an oral LOXL2 inhibitor to reduce fibrosis in patients with idiopathic pulmonary fibrosis (IPF). Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com