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New Anti-Inflammatory Peptide Proves to Be Highly Effective in Ulcerative Colitis: Presented at UEGW

By Adrian Burton

MADRID, SPAIN -- November 4, 2003 -- A joint U.K./Eastern European group has reported that a new decapeptide is highly effective in the treatment of ulcerative colitis.

The findings -- the work of a group spanning the U.K., Serbia, Bulgaria, the Czech Republic and the U.S. -- were revealed here November 3^rd at the 11^th United European Gastroenterology Week by Simon Travis, MD, consultant gastroenterologist at the John Radcliffe Hospital, Oxford, United Kingdom.

The new drug, RDP58, "is a novel decapeptide," explained Dr. Travis. "It's protease-resistant because it's made of D-amino acids." The compound is a potent anti-inflammatory molecule that inhibits production of pro-inflammatory cytokines by disrupting cell-signalling.

One hundred twenty-seven patients with mild-to-moderate active disease (simple clinical colitis index 4-9) were recruited to two parallel, prospective, randomised, blinded, placebo-controlled studies to determine the efficacy of RDP58. Patients were randomised to receive either a placebo (n = 13) or RDP58 at 100 mg (n = 21) in the U.K. or placebo (n = 30), 200 mg (n = 31) or 300 mg (n = 32) in the European partner countries for 28 days.

"Baseline characteristics were well-matched for age [between 41 and 56 years], gender and extent of disease," explained Dr. Travis.

Sigmoidoscopy and rectal biopsy were performed at days 0 and 28. Patients showing reductions in simple clinical colitis activity index (SCCAI) scores of 3 or more were classed as responders, while those showing 3 or less were considered to be in remission. The need for intensified anti-inflammatory therapy was classed as a failure.

At 28 days, the combined results showed clinical remission rates of 72%, 70%, 40% and 29% for the 300 mg, 200 mg, 100 mg and placebo doses, respectively (p = .0006). Response rates were 72%, 77%, 33% and 44% (p = .002). Those patients in the higher dosage groups (300 mg and 200 mg) also showed better histological scores than the placebo (p = .008). "The results of the U.K. arm of this study showed that 100 mg was not effective," said Dr. Travis.

The effects of the treatment lasted up to the end of the 28-day follow-up period in 87% of patients in the 200 mg/d group for whom results were available. Only 13% of these patients experienced a median 1 (1-2) point increase in their SCCAI scores, compared to 30% of patients in the placebo group (median 2 [1-5] point increase).

The adverse event profiles were not significantly different.

"We can conclude that RDP58 at 200 or 300 mg/d is effective in mild-to-moderate ulcerative colitis. But we can't assume there is a 300 mg ceiling, and we need to explore aspects such as the rectal bleeding response. But these are very encouraging results," Dr. Travis concluded.


[Study title: RDP58 -- Novel and Effective Oral Therapy for Ulcerative Colitis (UC): Results of Parallel Prospective, Multicentre, Placebo-Controlled Trials. Abstract Mon-OP-G-21]

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