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Synairgen to include more severe COPD patients in phase II SNG001 study

Regulators have given Synairgen the green light to include more severe COPD sufferers in the phase II trial of its SNG001 inhaler following a successful interim safety review
man coughing
The decision will help enrolment, which is expected to complete during the 19/20 virus season

Synairgen plc (LON:SNG) is to include patients with more severe chronic obstructive pulmonary disease (COPD) in the second part of the mid-stage study of its SNG001 drug.

The move comes after a successful interim safety review by the independent Data Safety Monitoring Committee (DSMC) which did not identify any safety concerns for patients currently enrolled in the trial.

READ: Synairgen making headway

“We welcome this decision from the DSMC, as it aids trial recruitment and enables us to dose patients who have a higher medical need,” said chief executive Richard Marsden.

“COPD exacerbations are the second most common cause of unplanned hospital admission in England, and we are pleased to have the opportunity to develop SNG001 to include these high-risk patients prior to potential hospitalisation.”

finnCap analyst Mark Brewer said the successful safety review was a “positive milestone” for Synairgen and supports the already established safety profile of SNG001.

“This will enable patients with more severe COPD to be included in the trial, with full enrolment still expected to complete in the 2019/20 virus season due to the milder start to this virus season.”

SNG001 showed promise in part one

SNG001 is a cold and flu treatment for COPD sufferers, whose symptoms – coughing, mucus production and shortness of breath – tend to be exacerbated by respiratory viral infections.

These exacerbations are a major healthcare burden and, as CEO Marsden said, the second most common cause of emergency hospital admissions.

READ: Synairgen kicks off part two of phase II COPD study

Part one of the phase II trial concluded earlier this year and involved dosing ten people who had no evidence of viral infection to examine levels of antiviral biomarkers in response to SNG001.

Results showed that not only is SNG001 safe and well-tolerated but that it also boosted anti-viral defences in the lung to prevent viruses spreading from the upper respiratory tract (nose, mouth and throat).

The aim of part two is to study the efficacy and safety of the inhaler in up to 120 COPD patients with a confirmed respiratory viral infection.

Synairgen shares were unchanged at 14.9p at the opening bell on Thursday.

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