A phase I clinical study for injectable, subcutaneous (SC) Belerofon began in Texas, US last month and the results of the trial are expected to be completed in Q3 2007. In February, Nautilus Biotech submitted an Investigational New Drug (IND) application for oral Belerofon to the FDA.
Oral Belerofon is the same molecular entity as SC Belerofon, but it has been formulated to be administered by mouth. In animal models, appropriate oral doses have shown that Belerofon can be absorbed from the intestine into the bloodstream and reaches blood levels comparable to those obtained by subcutaneously injected Interferon-alpha products.
The oral Belerofon phase I clinical trial will take place in the USA and will begin later in 2007. The trial will be an open-label, ascending dose study of four doses of oral Belerofon. The primary objective of the trial is to evaluate oral Belerofon in healthy adult subjects for safety, tolerability and pharmacokinetics.
Nautilus Biotech’s CEO, Dr Manuel Vega, said: “This is an important milestone in the development of treatments for a range of therapeutic diseases – all currently marketed interferon-alpha drugs are administered by injection and oral Belerofon is expected to result in improved safety and patient compliance.”