PARIS, October 10 /PRNewswire/ -- Nautilus Biotech has announced that it has submitted an Investigational New Drug (IND) filing to the U.S. Food and Drug Administration (FDA) for injectable BELEROFON(R), its protease-resistant, long-lasting Interferon (IFN) alpha. The drug candidate BELEROFON(R) has therapeutic potential for the treatment of a number of clinical diseases, including Chronic 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, resulting in improved safety and patient compliance.
Nautilus expects to commence a Phase 1 study in the US in Q12007, with the aim of confirming the enhanced pharmacological profile of subcutaneous BELEROFON(R).
BELEROFON(R) has been designed and developed using Nautilus Biotech's proprietary technology for protein engineering. It carries a single amino-acid substitution that renders the molecule highly resistant to proteases in blood and tissues, whilst its activity level and profile remain equivalent to native IFN alpha. Animal studies have shown that the particular mutation carried by BELEROFON(R) 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(R).
The improved pharmacokinetic profile of BELEROFON(R) is designed for once-a-week subcutaneous administration, which is the same as pegylated products currently available. However, because BELEROFON(R) has been shown to maintain a high level of activity, it is expected that it will be possible to administer the new drug at lower doses compared to established pegylated IFN alpha products. These factors should result in better safety and tolerability and greater patient compliance.
"This milestone reached with BELEROFON(R) is a key step in our commitment to develop innovative, high value and best-in-class therapeutic proteins. This is just the beginning of a sustained effort to aggressively move our pipeline of proprietary products into the clinic." said Nautilus Biotech CEO, Manuel Vega.
"We believe BELEROFON(R) can be given at a significantly lower dose compared to the current gold standard of care and this will give it an important competitive advantage over established pegylated IFN alpha products. Nautilus Biotech's technology has wide applicability across many therapeutic protein families. Increasing resistance to proteolysis offers important improvements in drug profiles and has the potential to create highly differentiated therapeutic products with better patient compliance." Said Paul Martin VP Strategy.
Notes to Editors:
BELEROFON(R) is Nautilus Biotech's proprietary variant of human IFN alpha that involves a single amino-acid change compared to native IFN alpha. The single point mutation introduced to create BELEROFON(R) has been specifically designed to increase the resistance of the entire molecule to proteolysis in blood, tissues and in the intestine. The increased resistance to proteolysis leads to a significantly improved pharmacokinetic and pharmacodynamic profile.
BELEROFON(R) shows the high biological activity associated with native IFN alpha, which is significantly greater than for pegylated derivatives. BELEROFON(R) is a non-pegylated, non-chemically modified, highly active, long-lasting in serum human interferon alpha.
About Nautilus Biotech
Nautilus Biotech is a drug discovery company with a pipeline of next-generation therapeutic proteins with superior pharmacological profiles that address unmet clinical needs. The Company's protein engineering technology can significantly improve the pharmacological characteristics of important blockbuster protein drugs, offering improvements in drug stability and administration. The Company is also creating proprietary 'third generation' therapeutic proteins which are, per se, suitable for oral administration.
The therapeutic proteins market is currently valued at over $30bn, and growing at a rate of 10-15% per annum. Nautilus has created a portfolio of next-generation therapeutic proteins with improved profiles, including long lasting Interferon alpha (Belerofon(R)), hGH (Vitatropin(TM)), Interferon beta, Clotting Factor IX, Erythropoietin, Interferon gamma and HMG-B1; it has established a strong intellectual property position covering enhanced versions of these multibillion dollars molecules and is rapidly moving these products towards clinical phases.
Nautilus Biotech is a private company with headquarters in Genopole(R) biopark, (Evry, France). For more information about Nautilus Biotech visit www.nautilusbiotech.com
For more information please contact:
At Nautilus Biotech:
Dr Manuel Vega, CEO
Nautilus Biotech SA
1 rue Pierre Fontaine
91000 Evry, France
At Northbank Communications
Lorna Watson, Account Director
Northbank Communications Ltd
The Media Village,
131-151 Great Titchfield Street,
London, W1W 5BB, UK
CONTACT: For more information please contact: Nautilus Biotech, Dr ManuelVega, CEO, Nautilus Biotech SA, 1 rue Pierre Fontaine, 91000 Evry, France,Tel: +33-1-60-87-54-60, Fax: +33-1-60-87-54-61, Email:firstname.lastname@example.org. Media relations: Northbank Communications, LornaWatson, Account Director, Northbank Communications Ltd, The Media Village,131-151 Great Titchfield Street, London, W1W 5BB, UK, Tel:+44-20-3008-7559, Fax: +44-20-3008-7551, Email:email@example.com