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news.Nautilus Biotech has submitted an investigational new drug filing to the FDA for Belerofon, its drug candidate that is a long-lasting interferon (IFN) alpha.
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Belerofon has therapeutic potential for the treatment of a number of clinical diseases, including hepatitis C.
It is expected that it will be possible to administer the new drug at a significantly lower dose while maintaining the weekly frequency of the established pegylated IFN alpha products. This could result in improved safety and patient compliance for the drug and possibly a competitive edge in the market for Nautilus Biotech.
Belerofon has been designed and developed using Nautilus Biotech’s proprietary technology for protein engineering. Animal studies have shown that the particular mutation carried by Belerofon confers longer half-life and an improved pharmacokinetic profile after subcutaneous administration compared to established pegylated and non-pegylated IFN alpha products. At the same time, the level of biological activity of the native IFN alpha, which is significantly lower in pegylated products, is fully maintained in Belerofon.
The improved pharmacokinetic profile of Belerofon is designed for once-a-week subcutaneous administration, which is the same as pegylated products currently available.