Preliminary results of a phase I clinical trial of CAT-354, a human anti-IL13 monoclonal antibody being studied as a potential treatment for severe asthma, showed CAT-354 to be well tolerated with no safety concerns identified.
The objective of the trial, which commenced in September 2004, was to assess the safety, tolerability and pharmacokinetics of CAT-354. The study of 34 mild asthmatic patients was double-blind and placebo-controlled by design. Researchers administered a rising single dose of CAT-354 intravenously to participants. Preliminary results showed that CAT-354 was well tolerated at all doses and there were no identified safety concerns.
Based on these results, the company is planning to start a clinical pharmacology study in the fourth quarter of 2005. This is being planned as a repeat dose allergen challenge study in patients with asthma.
Patrick Round, vice president of development at Cambridge Antibody, commented: “CAT-354 is an important product candidate for CAT (Cambridge Antibody Technology) and this trial was the first clinical step in its development as a potential treatment for severe asthma. We are encouraged by these preliminary results and are now moving forward with plans for a second clinical trial.”
Cambridge Antibody has already had success with its antibody program with a drug called Humira discovered in collaboration with Abbott. The product, now licensed to Abbott, has been approved for marketing as a treatment for rheumatoid arthritis in 58 countries.