Shionogi: Positive Results for Phase 3 Flu-Related Complications Study

Shionogi Presents Positive Results for Baloxavir Marboxil Phase III Study (CAPSTONE-2) in Individuals at High Risk for Influenza-Related Complications at IDWeek 2018

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) has announced that the results from the global phase III study (CAPSTONE-2) assessing baloxavir marboxil in individuals at high risk for influenza-related complications are being presented at IDWeek 2018, held in San Francisco on October 3-7, 2018.

Key results from CAPSTONE-2 are as follows:

Baloxavir marboxil significantly reduced the time to improvement of influenza symptoms (TTIIS, the primary endpoint) compared with placebo (median time of 73.2 hours versus 102.3 hours; p<0.0001) and met the study’s primary objective. In analysis for each influenza virus subtype, baloxavir marboxil significantly reduced TTIIS in influenza type A/H3N2 (median time of 75.4 hours versus 100.4 hours; p<0.05) and type B (median time of 74.6 hours versus 100.6 hours; p<0.05) compared with placebo.

Baloxavir marboxil demonstrated superior efficacy compared with placebo for important secondary endpoints:

• ・ Significantly reduced the length of time the virus continued to be released from the body (viral shedding; median time of 48.0 hours versus 96.0 hours; p<0.0001).
• ・ Significantly reduced the usage of antibiotics for infections secondary to influenza infection (3.4% versus 7.5%; p=0.01).
• ・ Significantly reduced the incidence of influenza-related complications (2.8% versus 10.4%; p<0.05)

Baloxavir marboxil was also shown to be effective compared with oseltamivir for key endpoints:

• ・ Numerically reduced the TTIIS (median time of 73.2 hours versus 81.0 hours; p=0.8347). In analysis for each influenza subtype, TTIIS was significantly reduced in influenza type B (median time of 74.6 hours versus 101.6 hours; p<0.05)
• ・ Significantly reduced the length of time the virus continued to be released from the body (viral shedding; median time of 48.0 hours versus 96.0 hours; p<0.0001)
• ・ Numerically reduced the incidence of influenza-related complications (2.8% versus 4.6%)

Baloxavir marboxil was well tolerated and no new safety signals were identified. Baloxavir marboxil had a numerically lower overall incidence of reported adverse events (25.1%) compared with placebo (29.7%) or oseltamivir (28.0%). The most common adverse events reported following treatment with baloxavir marboxil were bronchitis (2.9%), diarrhoea (2.7%), nausea (2.7%) and sinusitis (1.9%), all observed at a lower frequency than placebo.

The data from CAPSTONE-2 demonstrate that baloxavir marboxil provides a clinically meaningful benefit for patients who are most susceptible to influenza-related complications. There are no other medicines which have demonstrated clear benefit specifically in high-risk populations in clinical studies. It is remarkable that baloxavir marboxil demonstrated superiority to oseltamivir in shortening the duration of virus shedding and in resolving the symptoms of influenza B virus infection. Based on these results, Shionogi believes that baloxavir malboxil will become a promising treatment option for influenza A and B, not only for otherwise healthy patients but also for those with risk factors for influenza complications.

https://www.marketscreener.com/SHIONOGI-CO-LTD-6493659/news/Shionogi-Presents-Positive-Results-for-Baloxavir-Marboxil-Phase-III-Study-CAPSTONE-2-in-Individu-27366590/