SkyePharma PLC announced that its third phase III efficacy study evaluating Flutiform for the treatment of mild to moderate asthma in adolescent and adult patients has met its primary endpoints. This is the third of several clinical efficacy studies being carried out in preparation for regulatory filing and completes the original core clinical trial programme.

The study (SKY2028-3-001) was conducted in centres across North America and Europe. The full analysis set includes a total of 475 patients. The study was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre, 12-week study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform 100/10 micrograms twice daily) in a single inhaler (SkyePharma HFA pMDI) with the administration of placebo or fluticasone (100 micrograms twice daily) or formoterol (10 micrograms twice daily) alone in adolescent and adult patients with mild to moderate asthma. Patients were treated for 12 weeks after initial screening and a two to four week 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 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.

Ken Cunningham, COO and CEO-designate of SkyePharma, said: "This is the third of the core clinical efficacy trials to meet its primary endpoints. These studies together with the Phase III safety study have included a total of 1,861 patients. We are very pleased with the progress being made with the development of Flutiform and now look forward to the results of the one remaining clinical efficacy trial required for the US filing. This is being conducted by Kos Life Sciences (a wholly owned subsidiary of Abbott), and is on track to be fully recruited in July and completed in the second half of this year."

The results of Study 001, together with the long-term phase III safety trial reported last year and the two efficacy trials already reported on 30 April and 17 June 2008, respectively, and summarised again below, will form part of the New Drug Application (NDA) for US regulatory approval for Flutiform.

The first efficacy study, SKY2028-3-002, included 357 patients in North America. It was a randomised, double-blind, active-controlled, parallel group, stratified, 12-week design. It compared the safety and efficacy of Flutiform 100/10 micrograms versus the administration of fluticasone (100 micrograms twice daily) and formoterol (10 micrograms twice daily) alone in adolescent and adult patients with mild to moderate asthma. In a top line analysis of key results, the levels of improvement in FEV1 showed statistically significant differences in favour of Flutiform compared with both fluticasone and formoterol taken alone.

Study SKY2028-3-004 was conducted in 557 patients across the United States and Europe. It was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform 100/10 micrograms or 250/10 micrograms twice daily) versus the administration of either placebo or fluticasone (250 micrograms twice daily) or formoterol (10 micrograms twice daily) alone in adolescent and adult patients with moderate to severe asthma. In a top line analysis of key results, the levels of improvement in FEV1 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 compared with placebo.

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The company has twelve approved products in the areas of oral, inhalation and topical delivery.