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news.Biota Holdings has announced that its second generation, influenza treatment, CS-8958, has successfully completed its initial Phase II clinical evaluation, showing favorable outcomes against all measured endpoints.
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CS-8958 is a long acting neuraminidase inhibitor (LANI), and is co-owned with 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.
The study was conducted in accordance with guidance from the Japanese Pharmaceuticals and Medical Devices Agency. In the double-blinded trial, inhaled CS-8958 administered once only was statistically indistinguishable from 75mg of oseltamivir administered twice daily for five consecutive days.
Biota and Daiichi-Sankyo are satisfied that the safety, tolerability and efficacy data has fully demonstrated proof of concept for LANI and therefore intend to continue with the product’s clinical development.
The Phase II results are being used to finalize the design of the pivotal Phase III registration trial due to be conducted in the next northern hemisphere autumn/winter influenza season. It is intended that the Phase III study be pan-Asian and include Japan, Taiwan, Hong Kong and Korea.
A parallel Phase II study, undertaken elsewhere in Asia, has also completed dosing. The results of both trials will be used to support the international regulatory and development program planned for LANI. A range of other LANI type compounds are also co-owned by Biota and Daiichi-Sankyo and are in pre-clinical development under a grant from the US National Institutes of Health.