SkyePharma PLC announces that its second phase III efficacy study evaluating Flutiform for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoints. This is the second of several clinical efficacy studies being carried out in preparation for regulatory filing.

The study (SKY2028-3-004) was conducted in centres across the United States and Europe. The full analysis set includes a total of 557 patients. The study was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform 100/10µg or 250/10µg twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of either placebo or fluticasone (250µg twice daily) or formoterol (10µg twice daily) alone in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a 14 day run-in period.

In a top line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoint in the active treatment arms, showed statistically significant differences in favour of Flutiform compared with both fluticasone and formoterol taken alone. In addition, the results demonstrated a significantly lower number of discontinuations due to lack of efficacy for Flutiform as compared with placebo.

Flutiform HFA-MDI is a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler ("MDI"). The product incorporates a fast onset long-acting beta-agonist (formoterol fumarate) with the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane ("HFA") and is being developed for asthma. Flutiform is aimed at the market for combination steroid and long-acting beta-agonist inhalers which is forecast to be approximately US$10 billion worldwide by 2010. Flutiform is licensed in the US to Kos Life Sciences, a wholly owned subsidiary of Abbott.

Frank Condella, CEO of SkyePharma, said: "The preliminary results from this second double-blind, phase III study provide evidence of efficacy in moderate to severe asthma and represent another major step forward in the development of Flutiform. The last patient visits for the third Phase III efficacy study, SKY2028-3-001, took place in April 2008 and we expect to announce results shortly."

The results of Study 004, together with the long-term phase III safety trial reported last year and the first efficacy trial (key results published 30 April 2008), will form part of the New Drug Application ("NDA") for US approval for Flutiform. As announced on 30 April 2008, the first efficacy study (SKY2028-3-002) included 357 patients in a randomised, double-blind, active-controlled, parallel group, stratified, 12-week design, comparing the safety and efficacy of Flutiform 100/10µg twice daily in a single inhaler (SkyePharma HFA pMDI) versus the administration of fluticasone (100µg twice daily) and formoterol (10µg twice daily) alone in adolescent and adult patients with mild to moderate asthma. In a top line analysis of these key results, the levels of improvement in FEV1, the primary endpoint measured, showed statistically significant differences in favour of Flutiform compared with both fluticasone and formoterol taken alone.