Shionogi's flu treatment passes Phase III test

Shionogi & Co. Ltd. (Tokyo:4507) said influenza candidate S-033188 significantly reduced time to alleviation of symptoms vs. placebo (p<0.0001) in the Phase III CAPSTONE-1 trial, meeting its primary endpoint. The company plans to submit an NDA for the cap-dependent endonuclease inhibitor to Japanese regulators this year.

In CAPSTONE-1, 1,436 patients with influenza A or B received placebo, neuraminidase inhibitor Tamiflu oseltamivir, or S-033188. Shionogi said the candidate showed “similar” efficacy to Tamiflu on the primary endpoint. On secondary endpoints, Shionogi said S-033188 significantly reduced viral titer on the first and second days after dosing, as well as viral shedding, vs. Tamiflu and placebo. S-033188 also led to a significantly lower incidence of treatment-related adverse events vs. Tamiflu. The rate of treatment-related adverse events was comparable between the S-033188 and placebo groups...