Dermagen Reports Successful Phase I/IIa Clinical Trial for AtopicDermatitis

2009-12-02

LUND - December 2, 2009. DermaGen AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" - today announced that Dermagen AB has received promising results from a clinical Phase I/IIa study. DermaGen AB is developing a novel antimicrobial peptide (AMP) treatment for atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease where dry skin and the skin's weakened barrier function make patients susceptible to colonization by microorganisms, a triggering or exacerbating factor of the disease. The AMP has shown a broad spectrum of activity and is both bactericidal and fungicidal. In the clinical trial, the company's candidate drug clearly reached its primary objective, demonstrating a significant reduction of total microbes in eczemas compared to placebo. In addition to good safety and tolerability performance, the candidate drug also showed a trend towards improved eczema status. This is the first time a study has shown efficacy of AMPs for atopic dermatitis in man

Commenting on the study, DermaGen's Managing Director, Jan Alenfall, said, "Achieving such promising results from a first-time-in-man trial is very pleasing. The observed trend towards improvement of the disease condition provides particular encouragement. We will now initiate further clinical studies to substantiate this. Skin infection is recognized as an aggravating factor of atopic dermatitis. The development of a new class of treatment, capable of eradicating microbes with limited risk of microbial resistance development, is likely to have significant market appeal within this and other dermatological indications."

Jørgen Thorball, Pergamum's Chairman, stated, "DermaGen is a very exciting company with a strong technology platform. These promising clinical results go a long way towards establishing proof of concept within atopic dermatitis. They also strengthen the company's position as it explores additional, first-in-class opportunities for the candidate drug and other compounds for the topical treatment of dermatological infections, such as impetigo and infected wounds and burns."

The rapid resistance development by microbes limits the use of classical antibiotics for indications such as atopic dermatitis, especially for topical applications. DermaGen's AMP is derived from natural endogenous human proteins and there is low probability that it will induce resistance as it lack a specific molecular target on bacteria and other microbes. Anti-infective treatments represent the most important component of the global dermatology market, accounting for 31% of total market value, approximately USD 4 billion.

Conny Bogentoft, CEO of Karolinska Development, said, "Pergamum and its Operating Units form an important part of the Karolinska Development portfolio. They represent a strong offering in dermatology and wound healing markets with products targeting indications with significant unmet medical needs. It is encouraging to see the progress they are making in their clinical development programs."