Dermagen Reports Successful Phase I/IIa Clinical Trial for Atopic Dermatitis

December 2, 2009

LUND, Sweden, December 2 /PRNewswire/ — 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

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.”

Jorgen 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.”

About DermaGen

DermaGen AB is a specialty pharmaceutical company and world leader in the
research and development of endogenous antimicrobial peptides. Founded in
2004, DermaGen focuses on the development of topically applied products for
the prevention and treatment of bacterial and fungal skin infections. Novel
antimicrobial peptides are modified to increase their potency and stability,
facilitating the development of pharmaceutical products that fulfill unmet
medical needs and significantly improve quality of life for patients.
DermaGen partners with leading international pharmaceutical companies in the
dermatological field to ensure rapid and cost-efficient development. The
company is based in Lund, Sweden and is part of the Pergamum group of


About Pergamum

Pergamum AB is a new kind of biopharmaceutical company focusing solely on
dermatology and wound healing markets. The company currently has four
Operating Units, which it supports with strategic management, business
development, drug development and operational assistance as required.
Pergamum is a Karolinska Development AB company.


About Karolinska Development

Karolinska Development manages one of the largest portfolios of life
science companies in Europe. Using a unique, highly cost-efficient business
model, the management team guides the commercialization of world-class life
science innovations, helping to shape the next-generation pharma industry.
Since 2003, Karolinska Development has built a portfolio of some 40
companies; among the company’s projects 12 compounds are undergoing clinical
trials. The portfolio also includes a total of 19 potential first-in-class


About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammation of the skin that occurs
in persons of all ages but is more common in children. AD is a chronic,
itching, inflammatory skin disease, which is associated with asthma and/or
hay fever and a familial occurrence of these conditions.

The prevalence of AD has risen 3-4-fold over the last 30 years and is now
a major public health problem in the seven major markets, with 3% of the US
population suffering from AD. It has been reported to affect 10 % of children
and accounts for between 10 and 20 % of all visits to dermatologists.

There is considerable evidence that colonization or infection with S.
aureus is a triggering or exacerbating factor in AD. Superantigens produced
by the bacteria stimulate keratinocytes and T-lymphocytes, and trigger the
inflammatory process. The inflammation leads to an impaired skin barrier
function. Furthermore, endogenous antimicrobial peptides are low in patients
with AD, leading to a vicious cycle of S. aureus involvement in the disease.
Superantigens also act as potent inhibitors of steroid action, possibly
leading to steroid resistance.

The use of topically administered AMPs for control and normalization of
the bacterial and fungal flora is therefore a logical and attractive method
for interfering with the pathogenesis of AD. It is well established that
treatment of AD with steroids in combination with antibiotics is more
effective than use of steroids alone. In the light of current therapies,
endogenous AMPs will add an important new and significant therapeutic
modality to current treatments with a very low probability of inducing
bacterial resistance.

    For further information, please contact:

    Jan Alenfall, Managing Director, DermaGen AB
    Phone: +46(0)46-192-197 / Mobile: +46(0)709-315-115
    E-mail: jan.alenfall@dermagen.se

    Jorgen Thorball, Chairman, Pergamum AB
    Phone: + 45(0)307-786-27
    E-mail: jorgen.thorball@pergamum.com

    Conny Bogentoft, CEO, Karolinska Development AB
    Phone: +46(0)70-668-61-43
    E-mail: conny.bogentoft@karolinskadevelopment.com


Source: newswire

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