Canadian biopharmaceutical company Welichem Biotech has announced the filing with Health Canada of a clinical trial application for its lead, anti-inflammatory drug WBI-1001.
Subject to regulatory approval of this application, Welichem plans to initiate the clinical studies in Canada in the fall of 2009.
The application is for a three-month, double-blinded clinical trial in patients with chronic atopic dermatitis at three trial centers. This filing is a direct result of the successful completion of the long-term, investigational new drug-enabling toxicology studies announced in April 2009, said Welichem Biotech. Results of these long-term toxicology studies support additional, longer term clinical trials of WBI-1001.
WBI-1001 is a non-steroidal, anti-inflammatory drug candidate that has been shown in prior clinical trials to be effective and to have good safety profile, according to Welichem Biotech. WBI-1001 is a patented drug candidate that is being developed by Welichem as a new treatment for atopic dermatitis, psoriasis and related diseases.
Genhui Chen, CEO of Welichem Biotech, said: "We are very encouraged by the data on this non-steroidal, anti-inflammatory drug candidate. This application is a significant step forward in our drug development program."