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news.Daiichi Sankyo Co has announced that its anti-influenza drug, CS-8958, has started its pivotal Phase III trial for adults and Phase II/III trial for pediatrics.
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The Phase III clinical trial for adults is designed to test the efficacy and safety of CS-8958 in several hundred adult patients per group who have confirmed, naturally acquired influenza A or B.
The trial uses symptom resolution and fever as its endpoints after a single inhaled dose. In this double-blind non-inferiority study, it is expected to confirm that single inhalation of CS-8958 is equally effective to 75mg of oseltamivir administered orally twice daily for five consecutive days.
Also, the safety of CS-8958 will be assessed in this study. This study was named Marvel study, and is being conducted as multinational clinical study in Asia (Japan, Taiwan, Hong Kong, and Korea).
In the Phase II/III for pediatrics, the efficacy of symptom resolution and fever with the same dose regimens as adults will be confirmed, the company said.
CS-8958, a long-acting neuraminidase inhibitor, was discovered by Daiichi Sankyo and is co-owned with Biota Holdings. CS-8958 is an inhaled formulation for influenza treatment and it is expected that single administration of CS-8958 will be efficacious for the treatment of influenza.