Nautilus Begins Trial of Long-Lasting Interferon-Alpha Drug

Nautilus Biotech has announced it has initiated a Phase I clinical trial of subcutaneous Belerofon, its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic hepatitis C.

Following recent approval by the FDA, the Phase I clinical trial involves six treatment groups of eight male and female volunteers, ages 18 to 50. The trial is an open-label, ascending-dose study of four doses of subcutaneous (SC) Belerofon, which will be compared with SC administered IntronA and Pegasys (pegylated Interferon alfa-2a).

The primary objective of the trial is to evaluate SC Belerofon in healthy adult subjects, for safety, tolerability and pharmacokinetics in comparison with IntronA and Pegasys. The second objective is to evaluate the comparative pharmacodynamics of the three products. Nautilus Biotech expects initial results from the trial to be available during the third quarter.

Belerofon is an engineered 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 with non-pegylated IFNs. Following subcutaneous administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared with native IFN alpha and pegylated derivatives.