BioWorld International Correspondent

Swedish biotechnology firm Biovitrum AB moved its candidate Type II diabetes drug, BVT.3498, into a placebo-controlled, double-blind Phase II clinical trial that will involve more than 100 patients.

Recruitment for the multicenter study in Finland and Sweden has already commenced, said company medical director and vice president of clinical science, Fredrik Lonnqvist. "We expect to have the data from the study before the end of the year," he told BioWorld International.

This proof-of-concept trial will be closely watched. Mats Petersson, CEO of the Stockholm-based company, previously referred to BVT.3498 as "our jewel in the crown." The molecule is a selective inhibitor of the enzyme 11beta-hydroxysteroid dehydrogenase 1 (11beta-HSD1), which is attracting increasing attention as a target for treatment of metabolic disease. "As far as we know, we are far ahead in this area," Lonnqvist said. He is not aware, he added, of any other companies reaching the clinic with 11beta-HSD1 inhibitors. (See BioWorld International, Oct. 30, 2002.)

The enzyme converts the steroid hormone cortisol from an inactive to an active form, which has multiple physiological roles, including control of carbohydrate metabolism. Animal and human data suggest it may have potential as a target in Type II diabetes.

The primary endpoint in the Biovitrum trial is improved control of glycemia or blood sugar levels. The presumed cause would be a reduction in cortisol action. "I think what is important here is predominantly the effects in the target organs," Lonnqvist said.