SkyePharma PLC (SKP.L, SKYE), a specialty pharmaceutical company based in London, said Tuesday that its development and marketing partner Mundipharma has reported positive results in two Phase III clinical studies for the European development programme related to Flutiform, being developed for asthma.
Study FLT-3501 assessed 182 patients, suffering from mild to moderate-severe persistent and reversible asthma, who were treated as per the protocol. The randomised, open label, parallel group study compared Flutiform pMDI to Seretide pMDI, to demonstrate comparable efficacy between treatment arms. Enrolled patients needed to have a disease history of at least six months and were treated for 12 weeks.
Mean pre-dose Forced Expiratory Volume in the first second or FEV1 was the primary parameter measured. The top line analysis shows that this end point was successfully met. The statistical analysis of both treatment groups indicated an improvement in lung function from the baseline measurement whilst the performance of Flutiform was not statistically inferior to that of Seretide.
Study FLT-3505 analysed 196 adult and adolescent patients suffering from mild to moderate-severe persistent and reversible asthma. The randomised, open label, parallel group study compared Flutiform pMDI to its individual components, fluticasone and formoterol. These were administered concurrently to demonstrate non-inferiority of Flutiform to the other treatment arm based on FEV1.
Enrolled patients were again treated for 12 weeks. Top line statistical analysis of the primary parameter confirmed that Flutiform is not inferior compared with the concurrent administration of fluticasone and formoterol.
Commenting on the results, SkyePharma's Chief Operating Officer, Dr Ken Cunningham, said: "We are delighted that along with the three Phase III pivotal efficacy studies conducted for NDA submission, we now have two further Phase III studies for European regulatory submission that have met their primary endpoints."
SKP.L closed Tuesday's regular trade on LSE at 3.03 pence, up 12.22% from the previous close.
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