Nautilus files Belerofon IND

Paris, France-based Nautilus Biotech has submitted an Investigational New Drug filing to the US Food and Drug Administration for oral Belerofon, its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic hepatitis C, the firm notes. The new drug will be administered orally - all currently marked interferon-alpha drugs are given by injection - resulting in improved safety and patient compliance. This IND for oral Belerofon follows Nautilus' recent filing for an injectable form last October.

Belerofon is a designed variant of IFN-alpha. It has a single point mutation for lower sensitivity to protease-mediated degradation, unchanged molecular weight and specific antiviral activity compared to non-pegylated IFNs. Following subcutaneous (SC) administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native IFN-alpha and pegylated derivatives. Nautilus Biotech has formulated lyophilized Belerofon together with inactive ingredients to produce enteric coated tablets.