LANI Phase III Clinical Trials Set For Enrolment
News Nov 18, 2008
Biota Holdings Limited has announced that the multiple centres involved in the Phase III clinical trail on its long acting neuraminidase inhibitor (LANI) CS-8958 are ready to commence treatment. Patients are expected to enroll into the study progressively throughout the Asian influenza season.
The Phase III multi centre study will be conducted in Japan, Taiwan, Hong Kong and Korea involving adult patients who have confirmed, naturally acquired influenza A or B. The trial will use time to symptom resolution as its primary end point, after a single inhaled dose of CS-8958. The double blind, non-inferiority study uses 75 mg of oseltamivir, twice daily for five days as its control. Safety will be also assessed in the study.
A second Phase II/III paediatric study will also be conducted in Japan on children of less than nine years of age. This study will use the same primary end point as the adult study, but a dose of 2 mg/kg of oseltamivir, twice a day for five days, as the control.
The duration of the studies will depend on the availability of patients for the trials and the severity of the Asian influenza season.
CS-8958 is a long acting neuraminidase inhibitor, discovered by Daiichi Sankyo and co-owned with Biota. A total of US$5.6 million of western clinical programs for CS-8958 have been or are intended to be funded by the US National Institute of Health.
The drug’s profile suggests that a single inhaled dose of CS-8958 should be efficacious for the treatment of influenza and an inhaled dose once a week, to maintain prophylaxis. Pre-clinical tests have shown CS 8958 to be effective against influenza A & B virus as well as against the H5N1 avian influenza virus.