MAL is a cream formulation containing methyl aminolevulinate, the same active substance used in the Metvix cream. MAL PDT is a photodynamic therapy that combines the MAL cream with controlled illumination by a red light source. The cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light.

The mechanism of action appears to involve killing of bacteria as well as specific action on sebaceous glands and inflammatory cells.

Photocure has completed a proof-of-concept study, which was designed to compare the efficacy of MAL PDT to placebo PDT. The study included 30 patients with moderate to severe acne, and the results show that MAL PDT gave a significantly greater reduction in the number of inflammatory acne lesions than placebo PDT 10 weeks after treatment.

Clinical trial programmes

The first phase II study has been initiated and will be reported in the third quarter of 2006. This study includes up to 43 patients with moderate to severe inflammatory acne and is designed to select doses for a confirmatory phase II study.

A clinical programme, including phase III studies, is under development. Regulatory agencies have been contacted for guidance with respect to the development programme.