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Rdp58 Is a Novel and Potentially Effective Oral Therapy for Ulcerative Colitis

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.