The long-term toxicology studies that are currently underway are designed to support the filing of an investigational new drug application (IND) for WBI-1001 with the FDA so as to initiate Phase II/III clinical studies in the US. Welichem intends to submit an IND for WBI-1001 in the fall of 2009, following successful completion of the toxicology program.
Building on the successfully completed, 28 day clinical trials of the non-steroid WBI-1001 cream on patients with chronic atopic dermatitis (AD) and with psoriasis, plans are now progressing towards an international Phase II/III clinical program. The IND-enabling toxicological evaluation is part of the program that is required as a prelude to the clinical trials.
WBI-1001 is a novel, patented drug candidate that is being developed by Welichem as a new treatment for AD, psoriasis and related diseases.