AstraZeneca forced to abandon Phase II trial

pharmafile | October 12, 2016 | News story | Research and Development AstraZeneca, Synairgen, asthma, cold, common cold 

Synairgen, a respiratory drug discovery and development company, has developed a drug, AZD9412, alongside AstraZeneca to treat and prevent severe asthma exacerbations. The treatment had reached a Phase IIa trial stage but had to be abandoned as not enough patients reported severe exacerbations to test the drug upon. This rendered the study void, as not enough patients could reach the primary endpoint.

The aim of the study was to use AZD9412 and a placebo measured against one-another upon the onset of colds in the patients. Colds are often found to cause severe exacerbations within asthma sufferers. AZD9412 is an inhaled interferon beta, an antiviral protein – with the premise being that the drug could help exacerbations, caused by the common cold, from developing.

In the trial, however, not enough of the patients were found to have been exacerbated by the onset of the cold and therefore the study was rendered void.

Richard Marsden, Synairgen’s Chief Executive Officer, commented on the failure of the trial by commenting: “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.”

Those involved in the trial now may have to potentially redesign the trial, given the failure in its current state. The possibility that this failure may have been due to patient selection and environmental/regional factors was mentioned by Synairgen in their report. 

Ben Hargreaves

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