“significant” preclinical trial results

Peptech Limited (PTD) today announced it had achieved “significant” preclinical trial results for its human domain antibody (dAb) therapeutic, with the candidate recording potency levels approximately three times higher than a leading blockbuster anti-TNF drug against rheumatoid arthritis in an industry standard model.


The biotechnology company said the domain antibody against tumour necrosis factor-á (TNF), used for the treatment of multiple inflammatory diseases such as rheumatoid arthritis and Crohn’s disease, successfully and dose-dependently suppressed disease development.

Peptech executive chairman Mr Mel Bridges said the group had completed extensive work over the past year in improving the acceptability of the anti-TNF dAb as a potential drug in humans and increasing its commercial potential.

“We have advanced our anti-TNF dAb considerably over the past 12 months through further engineering and preclinical development,” he said.

“Our current work is at the forefront in the development of effective treatments for a wide range of inflammatory diseases,” Mr Bridges added.

Peptech R&D director Dr Phil Jennings said the strong performance of the anti-TNF dAb in preclinical studies conducted to date gave Peptech strong confidence the drug candidate could be successfully commercialised.

“The model used in the preclinical trial was the same model used in the commercialization of marketed blockbuster anti-TNF drugs, which reinforces our conviction that this candidate has the potential to become one of the next generation in anti-inflammatory treatments,” he said.

Dr Jennings noted that the drug candidate had now entered the initial phase for quantity production under the conditions of Good Manufacturing Practice (GMP), to enable quality and quantity suitable for further preclinical and clinical testing.

“Our focus is on continuing to advance the preclinical development of the anti-TNF dAb, with an expectation of reaching the clinic in 2007,” he said.

“Our recent move to new premises has enabled us to undertake early stages of production, reducing the company’s reliance on outsourcing and resulting in ongoing cost savings,” Dr Jennings stated.

Mr Bridges said therapeutic biologicals represented a major commercial opportunity, with the company’s anti-TNF dAb targeted at a market with 2004 product sales in excess of US$6 billion.

“We hold a very strong intellectual property position in anti-TNF’s, and are in the enviable position of receiving ongoing strong revenue streams from our existing TNF license agreements with Abbott and Centocor,” he said.

“Peptech has never been better positioned — we have a spread of risk, ongoing revenue streams and a promising development pipeline with products directed at two of the world’s largest markets; cancer and inflammation,” he concluded.