Idera Pharmaceuticals has concluded enrolling patients in double-blind, placebo-controlled Phase 2 trial assessing IMO-3100 in psoriasis patients.
The study randomized 44 patients suffering from moderate to severe plaque psoriasis with IMO-3100 at 0.16mg/kg or 0.32mg/kg or placebo in 1:1:1 ratio by subcutaneous injection once every week for four weeks.
The dug safety will be assessed throughout the treatment and four-week follow-up periods.
Idera clinical development vice president Dr. Robert Arbeit said the Phase 2 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,” Dr. Arbeit added.
Psoriasis intensity, using PASI, mean focal psoriasis severity and PGA scores, will be compared at end of treatment to pre-treatment.
The average epidermal thickness earlier to the treatment and at end of treatment will even be determined through biopsy analysis.
Idera expects top-line data from the study, that is being conducted at multiple sites in the US, by the end of 2012.
