IDEA AG starts Phase II study with IDEA-070 for treatment of various inflammatory skin diseases

Munich, Germany – February 2005. IDEA AG, a leader in targeted therapeutics, announces today the start of a clinical phase II study, which tests the safety and efficacy of IDEA-070 for the treatment of various inflammatory skin diseases.

The main aim of the double-blind, placebo-controlled study with IDEA-070 is to identify dermatological diseases that might benefit from topical treatment with IDEA-070. Subsequently, IDEA-070 will be further tested in a phase III program focusing on such selected dermal maladies.

The study will test the safety and efficacy of IDEA-070 for the treatment of diseases displaying inflammatory reactions as part of their etiopathogenetic background, such as atopic eczema, dishydrotic hand eczema, plaque type psoriasis, seborrheic eczema, and acne vulgaris.

The focus of the study will be on comparing the clinical benefit to patients with the above mentioned different diseases after either topical application of IDEA-070 or the matching placebo over a three week treatment period. In total, 225 patients will be enrolled at six centres in Germany. Prof. Dr. Thomas A. Luger, Director of the Clinic and Outpatient Department of Dermatology at the University of Münster, Germany and Secretary General of the German Society of Dermatology, will be the coordinating investigator.

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For further information, please contact:

IDEA AG Tel: +49 89 324 63 30
Matthias Rother MD PhD, Executive Board, Head of Research and Clinical Development
Evert Küppers MSc. MBA, Head of Business Development

Notes to the editors:

IDEA AG is a privately held biopharmaceutical company with headquarters in Munich, Germany. IDEA develops and commercialises non-invasive, targeted therapeutics based on stable, ultra-deformable carriers that are typically applied on the skin. These proprietary carriers are driven through the skin barrier by the local water gradient and can be engineered to achieve a high, localised drug concentration at the site of application and deep below. This method of application can diminish the local or systemic adverse side effects of a drug, and often increase its potency. To date, 47 patents from 8 patent families have been granted to the Company to protect its technologies.

Background information:

Product IDEA-070

IDEA AG has developed a novel Transfersome ® -based dosage form of an analgesic (IDEA-070) to treat inflammatory, painful skin conditions.
In a previous double-blind, placebo and active controlled clinical study, the safety and efficacy of IDEA-070 were investigated in UVB-induced sunburn, as a model of skin pain and inflammation. All three tested doses of IDEA-070 were significantly superior to placebo and hydrocortisone acetate, both immediately after UVB exposure and after a delayed treatment of six hours following skin exposure to UVB light. Moreover, IDEA-070 showed a good safety profile, with no evidence of local or systemic intolerance.

Skin inflammation / skin pain

Skin inflammation is defined by a cascade of events involving soluble mediators, free oxygen radicals and proteins expressed on the cellular surface. Inflammatory reactions are part of the etiopathogenetic background of various skin disorders, including atopic eczema, dishydrotic hand eczema, plaque type psoriasis, seborrheic eczema, and acne vulgaris. IDEA-070 contains an analgesic, anti-inflammatory drug that acts by inhibiting both cyclooxygenase (COX-1 and COX-2) as well as lipoxygenase activity; the product candidate therefore can reduce prostaglandin and leukotriene mediated inflammatory reactions.

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