BioWorld International Correspondent

LONDON Celltech Group plc said Phase II trial results for its antibody drug, CDP 870, in Crohn’s disease demonstrated the drug was effective and safe, but the study did not reach statistical significance because of a very high placebo response rate.

The Slough-based company said it expected to start Phase III studies during 2002. Celltech CEO Peter Fellner commented that the results “provide us with confidence in proceeding to late-stage clinical trials.”

Michael King, analyst at WestLB Panmure, was less effusive. “Given the likely price of CDP 870, we would have hoped for more differentiation from placebo if the product is going to be a commercial success.”

The Phase II study involved 292 patients in four dosage groups, with each group receiving an injection monthly for three months. Statistically significant clinical responses were noted as early as week two, and were maintained throughout the treatment period.

The highest response rate (54 percent) was seen in the group treated with the highest dose of 400 mg per month. However, there was a 29 percent response rate in the placebo group and therefore the study did not reach significance at 12 weeks.

CDP 870 was well tolerated, and no safety issues were identified. There was no difference in reported side effects in any group, including placebo.

If it achieves registration, CDP 870 is expected to have an edge over the only other biological product on the market for Crohn’s disease, Johnson & Johnson’s Remicade, because CDP 870 is administered by monthly injection and Remicade requires intravenous infusion.

CDP 870 also is being developed for the treatment of rheumatoid arthritis by Celltech’s partner, Pharmacia Corp., of Peapack, N.J. Results from Phase II were announced in November, and Pharmacia is initiating Phase III studies.