Enhance begins PIIa for Gingivitis

Enhance Biotech, a developer of a portfolio of products focused on lifestyle drugs, has commenced Phase IIa trials of its compound LI 401 for the treat-ment of gingivitis.

The product has a unique patented approach to eliminating the problems of inflammation in the gums, through a medicated mouthwash using LI401 as the active ingredient. The University of Bristol Dental School in the United Kingdom, one of Europe's leading dental universities, will be preparing the trial material and conducting the Phase IIa trial.

Gingivitis is a condition typified by the swelling and redness of the gums and bleeding during cleaning and is recognised as an early sign of gum disease. The disease is caused by the build up of bacterial plaque on the teeth adjacent to the gum margin. Symptoms include red and swollen gums, bad breath, and sepa-ration of the gums from the teeth, creating spaces where further plaque build up and gum separation can occur. Although usually painless, it can be the precur-sor of a more serious periodontal condition unless treated effectively.

The objective of the trial is to assess the ability of a novel anti-inflammatory mouth rinse to inhibit gingivitis. The design will be a single centre, two-way crossover study in healthy volunteers comparing the gingivitis inhibitory effects of LI 401 with a placebo control. The trial is planned, following recruitment, to commence in the last quarter of the year, completing early in 2005.

Enhance's chief science officer Sam McCormick said: 'We are excited about the potential for this product since this area of healthcare has seen relatively little innovation over the years, and the product has the potential to provide a radical new approach to the problem of gingivitis.'