SkyePharma PLC (LSE: SKP) announced last week that its development and marketing partner Kyorin Pharmaceutical Co, Ltd. (“Kyorin”) has successfully completed the Phase III clinical studies for the Japanese development programme for KRP-108 (flutiform®), with both studies (A301 and A302) meeting their primary endpoints. This will enable the regulatory filing with the Japanese authorities to take place in Kyorin’s fiscal year ending in March 2013 as planned.
Study A301 included patients suffering from asthma. They were treated in an eight week single-blind, randomised multiple centre, two arm parallel group study, to assess the efficacy and safety of KRP-108. The two treatment arms were: (1) KRP-108; and (2) Flutide 50 (fluticasone).
The changes in the mean values of morning PEF (Peak Expiratory Flow) was the primary endpoint measured. The top line analysis confirms that KRP-108 achieved consistently higher results when compared with Flutide® 50 and demonstrated that KRP-108 was well tolerated in the study patients.
Study A302 included patients suffering from mild to severe asthma. They were treated over 52 weeks in an open-label, multiple centre three arm study to assess the safety and efficacy of KRP-108. The results are consistent with the large safety database already accumulated on flutiform®.
Peter Grant, Chief Executive Officer of SkyePharma, commented:
“We are very pleased that studies A301 and A302 have met their primary endpoints. Results from the studies further confirm the efficacy and safety of KRP-108/flutiform. The successful completion of these studies will enable the Japanese New Drug Application to be filed as planned in Kyorin’s fiscal year ending in March 2013.”