Biota's novel antiviral "indistinguishable" from oseltamivir

Melbourne, Australia-based Biota Holdings says that its second-generation influenza drug, CS-8958, has successfully completed an initial Phase II evaluation, showing favorable outcomes against all measured endpoints. The drug's first Phase III trial is scheduled to commence later this year.

The agent is a long-acting neuraminidase inhibitor, and is co-owned with Japan's Daiichi Sankyo. The Phase II clinical trial was designed to test the safety and efficacy of CS-8958 in several hundred adult patients who had confirmed, naturally-acquired influenza A or B using fever and symptom resolution endpoints after a single inhaled dose.

In the double-blinded trial, inhaled CS-8958 administered once only was statistically indistinguishable from 75mg of oseltamivir, the active ingredient in Roche's blockbuster antiviral Tamiflu, administered twice daily for five consecutive days.