Welichem Biotech Inc (BURNABY, British Columbia, Canada), is a publicly-traded biotechnology company developing therapeutic drugs in the fields of autoimmune, inflammatory diseases, and cancer. The company announced positive results from a randomized, double-blind, phase I clinical trial conducted in Montreal Canada evaluating topically applied WBI-1001, a small molecule compound, in 36 psoriasis patients. The trial met both its primary and secondary objectives.

The primary objectives evaluated the safety and tolerability, and assessed the pharmacokinetics of the topical agent. The secondary objective evaluated the efficacy of the WBI-1001 cream, including physician’s global assessment (PGA), induration, erythema, scaling, and body surface area (BSA).

The trial was conducted through six separate treatment groups, each comprising six patients with mild-to-moderate psoriasis. All patients within a given treatment group received the same dosage of WBI-1001 on one side of body and placebo on the other side. Each treatment group received WBI-1001 in a dosage of 0.5%, 1%, or 2% on the affected areas either once or twice a day.

The agent demonstrated an acceptable noncutaneous safety profile. The 0.5% and 1% doses exhibited favorable good skin tolerance in this study. Some patients who were treated with WBI-1001 2% experienced mild skin-related adverse events, which are common to established topical therapies for psoriasis. There were no serious adverse events. The results of the pharmacokinetic study showed extremely low concentration of WBI-1001 in the blood. There was no evidence that the agent accumulated systemically with once or twice daily application over a period of 28 days.

Overall, data from the study suggest that WBI-1001 cream is efficacious on psoriasis as demonstrated by greater improvement in PGA, induration, erythema, and scaling compared with the placebo cream. After 28 days of treatment, mean scores for PGA, induration, erythema, and scaling for all subjects were reduced from baseline appreciably more for the WBI-1001-treated side of the body than for the placebo-treated side. Improvement in the mean scores for PGAs, induration, erythema, and scaling started around Day 14, and was maintained or further increased up to Day 35 (7 days postdose) in the majority of the treatment groups. The short-term nature of the study did not allow treatment differences to emerge between treatment groups in BSA criterion.

A phase II study to confirm and further explore WBI-1001 as a topical cream application against mild-to-moderate psoriasis is planned for 2009. Mechanism of action studies suggest that the agent disrupts the key pathologies of the disease by selectively blocking T-cell activation, modulating neutrophils, and by inhibiting kinase, pro-inflammatory cytokines, and cell migration. Welichem may also advance WBI-1001, a small molecule that is easily suitable to oral formulation, in studies targeting inflammatory bowel disease.