Daiichi Sankyo Reports Phase III Results Of CS-8958 Study

Daiichi Sankyo has reported the top line results from a phase III study of the anti-influenza virus agent, CS-8958.

The study, named MARVEL (Multinational Asian Clinical Research for Influenza Virus Extermination on Long-Acting Neuraminidase-Inhibitor study), was a randomized, double-blind, and active-controlled study. It was intended to confirm the efficacy and safety of CS-8958 administered as a single inhaled dose of 20 or 40mg, as compared to oseltamivir phosphate 75mg orally administered twice daily for 5 days in adult patients with influenza A or B virus infection.

According to the results, non-inferiority to oseltamivir phosphate was confirmed in both the 20mg group and 40mg group of CS-8958 in terms of the primary endpoint, which was the time to alleviation of influenza illness.

In the comparison between the dose groups of CS-8958, 40mg group was superior to 20mg group in efficacy. Both 20mg and 40mg of CS-8958 were well tolerated, said the company.

In addition, Daiichi Sankyo has conducted a randomized, double-blind, active-controlled phase II/III study for pediatric use in parallel with MARVEL study, and the efficacy and safety of CS-8958 administered as a single inhaled dose of 20 or 40mg was compared to oseltamivir phosphate as well.

The results showed that both 20mg group and 40mg group of CS-8958 were better than oseltamivir phosphate group in efficacy. In addition to that, 20mg and 40mg of CS-8958 were well tolerated in pediatric patients.