RDP58 is a novel and potentially effective oral therapy for ulcerative colitis.

Travis, S; Yap, L; Hawkey, C; Warren, B; Lazarov, M; Fong, T; Tesi, R

Journal article

RDP58 is a novel and potentially effective oral therapy for ulcerative colitis.

Abstract:: BACKGROUND: RDP58 is a novel anti-inflammatory d-amino acid decapeptide that inhibits synthesis of proinflammatory cytokines by disrupting cell signaling at the pre-MAPK MyD88-IRAK-TRAF6 protein complex. We therefore evaluated its efficacy and safety in parallel multicenter, double-blind, randomized concept studies in ulcerative colitis (UC). METHODS: In the first trial, 34 patients with mild to moderate active UC were randomized (1:2) to placebo (n = 13) or RDP58 100 mg (n = 21). In the second trial, 93 similar patients were randomized (1:1:1) to placebo (n = 30) RDP58 200 mg (n = 31), or RDP 300 mg (n = 32). In both studies, treatment success was defined as a simple clinical colitis activity index score of no more than 3 at 28 days. Sigmoidoscopy and rectal biopsy (at baseline and 28 days) and safety measures (baseline and 28 and 56 days) were other endpoints. RESULTS: Treatment success on RDP 100 mg was 29% versus 46% on placebo (P = 0.46). There were no significant differences in sigmoidoscopy or histology score. In the second study, treatment success on the higher doses of RDP58 (200 and 300 mg) was 71% and 72%, respectively, versus 43% on placebo (P = 0.016). Improvements in sigmoidoscopy scores (41% on 200 mg and 46% on 300 mg versus 32% on placebo) did not reach significance, but histology scores improved significantly (P = 0.002) versus placebo. Overall, adverse events were no different between placebo (3.3 +/- 2.4) and RDP58 (2.7 +/- 1.4, 300-mg group). CONCLUSIONS: RDP58 at a dose of 200 or 300 mg, but not 100 mg, was effective in mild-to-moderate UC. RDP58 was safe and well tolerated, and its novel action makes it an attractive potential therapy.

Publication status:: Published

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APA Style

Travis, S., Yap, L., Hawkey, C., Warren, B., Lazarov, M., Fong, T., & Tesi, R. (2005). RDP58 is a novel and potentially effective oral therapy for ulcerative colitis. Inflammatory Bowel Diseases, 11(8), 713–719.

MLA Style

Travis, S., et al. “RDP58 Is a Novel and Potentially Effective Oral Therapy for Ulcerative Colitis.” Inflammatory Bowel Diseases, vol. 11, no. 8, 2005, pp. 713–19.

Chicago Style

Travis, S, L Yap, C Hawkey, B Warren, M Lazarov, T Fong, and R Tesi. 2005. “RDP58 Is a Novel and Potentially Effective Oral Therapy for Ulcerative Colitis.” Inflammatory Bowel Diseases 11 (8): 713–19.
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