Idera Pharmaceuticals has finished enrolling patients in a double-blind Phase II trial evaluating IMO-3100, an antagonist of specific toll-like receptors (TLRs), in psoriasis patients.
The placebo-controlled study randomised 44 moderate-to-severe plaque psoriasis patients with IMO-3100 at 0.16mg/kg, 0.32mg/kg or placebo by subcutaneous injection once every week for four weeks in a 1:1:1 ratio.
Idera clinical development vice president Dr Robert ARBEIT said the Phase II proof-of-concept study is evaluating multiple endpoints to assess the clinical activity of IMO-3100, including the impact on Psoriasis Area Severity Index (PASI), mean focal psoriasis severity, and Physician Global Assessment (PGA) scores.
"In addition to the clinical assessments, we are evaluating biopsies of psoriasis plaques for treatment-related changes in epidermal thickness and immune cell infiltrates consistent with the intended mechanism of action," Arbeit said.
The safety profile of the drug will be assessed throughout the treatment and during four-week follow-up periods.
Psoriasis intensity at the end of the treatment, assessed using PASI, mean focal psoriasis severity and PGA scores, will be compared to pre-treatment levels.
The average epidermal thickness prior to the treatment and at end of treatment will also be determined through biopsy analysis.
Idera expects top-line data from the study, being conducted at multiple sites in the US, by the end of 2012.
Idera chief executive officer Dr Sudhir Agrawal said; "We expect our phase II study of IMO-3100 and planned clinical trials of IMO-8400 will help us to establish the benefits of inhibiting toll-like receptor-mediated pathways, which include controlling the induction of multiple cytokines, such as TNF-a, IL-12, IL-6, and IL-17, as well as downstream signaling."