FDA OKS Santalis' Phase 2 Study of EISO For AD

The U.S. Food and Drug Administration (FDA) has green lighted Santalis Pharmaceuticals Phase 2 clinical study of East Indian Sandalwood Oil (EISO) cream for the treatment of atopic dermatitis (AD).

The multi-center, placebo controlled, double blinded, Phase 2 efficacy and tolerability study for the treatment of mild to moderate AD will include patients 17 years of age or older with a clinically stable diagnosis of atopic dermatitis with a total body surface area (BSA) involvement of not more than 15 percent. Up to 72 patients will be enrolled to determine preliminary efficacy after 28 days of a twice-a-day treatment using a unique 5% East Indian Sandalwood Oil (EISO) cream formulation.

These Phase 2 studies follow on from a prior open-label study in the U.S., which demonstrated an over-the-counter formulation of EISO in combination with colloidal oatmeal to be safe, well tolerated, and efficacious for patients aged between 3 months and 12 years who had mild, moderate or severe eczema affecting a large percentage of their BSA.

The pharmaceutical-grade EISO from Austalia's TFS Corporation Ltd. (Santalis’ parent company) has been demonstrated to inhibit a broad range of inflammatory and proliferative pathways thought to underlie this condition, including down-regulation of phosphodiesterase (PDE4) activity. In addition, EISO is effective in controlling many pathogens associated with secondary infections of AD, such as Staphlococcus aureus.