Pergamum announces final data from Phase I/II study of LL-37 in patients with chronic leg ulcers

STOCKHOLM – October 10, 2013. Pergamum AB, which is a portfolio company of
Karolinska Development AB, announced today that it has finalized the Clinical
Study Report of a randomized Phase I/II trial of LL-37 for treatment of venous
leg ulcers. Patients treated with LL-37 had a statistically significant improved
healing rate compared with placebo and no safety or tolerability concerns were
noted, confirming the positive preliminary data reported in July this year.
Chronic leg ulcers are often defined as those that fail to heal after six weeks
or more of appropriate treatment. Venous leg ulcers are the most common type of
hard-to-heal leg wounds, accounting for >70% of all cases in the developed
world.

LL-37 is a human peptide that is involved in acute wound healing. Data from
independent research groups suggest that chronic wounds have a relative deficit
of LL-37 and should benefit from therapeutic, exogenous application of the
peptide.

Jonas Ekblom, CEO of Pergamum commented: “This was primarily a safety study but
the data also show that LL-37 has an effect in this difficult to treat patient
group, which has been lacking access to new innovative pharmaceutical products.
Pergamum’s candidate drug has the potential to become the first in a new class
of pharmaceuticals for chronic leg ulcers, a major medical problem. The
worldwide wound care market today is worth over EUR 10bn.”

In a double blind multicenter study, 34 patients with venous leg ulcers received
either placebo or one of three different doses of LL-37 (0.5, 1.6, and 3.2
mg/ml) of Pergamum’s potential first-in-class therapeutic peptide LL-37 in a gel
formulation. The primary objective of the trial was to assess the safety and
tolerability and the data demonstrate that there are no safety concerns with LL
-37. The investigational drug was well tolerated when it was applied to venous
leg ulcers at the two lower doses (0.5 mg/mL and 1.6 mg/mL). However, an
increased incidence of local reactions at the treated wounds was observed in the
highest dose group (3.2 mg/ml).

The results also show that the healing rate for the patients who received the
lowest dose (0.5 mg/ml) and the middle dose (1.6 mg/ml) of LL-37 were
approximately 6 and 3-fold higher respectively, compared to the patients who
received placebo (p=0.003 for 0.5 mg/mL and p=0.088 for 1.6 mg/ml). There was no
improvement in healing rate in the highest dose group. The clinical trial report
thereby confirms the positive top-line data reported earlier this year.

”The fact that statistically verifiable clinical performance of an
investigational drug can be demonstrated in a relatively small study is rare.
This is especially so in the treatment of venous leg ulcers. These findings
suggest that LL-37, in conjunction with compression, could be a very promising
new treatment”, said Richard White, Professor of Tissue Viability, Institute of
Health & Society, University of Worcester.

“Now that the clinical trial report has been finalized, Pergamum will focus its
efforts on finding the right industrial partner to bring this novel treatment
concept to market”, said Torbjörn Bjerke, CEO of Karolinska Development AB and
Chairman of the Board of Pergamum.

For further information, please contact:
Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)8 470 37 40, e-mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

Benjamin Nordin, IRO, Karolinska Development AB
Phone: +46 (0)73 093 60 80, e-mail: benjamin.nordin@karolinskadevelopment.com

TO THE EDITORS

About Pergamum
Pergamum is a biopharmaceutical company specialized in the development of
therapeutic peptides for local application in infections and wounds. The
company’s vision is to develop a portfolio of unique development programs
representing high medical value that ultimately, through global partnerships,
will result in first-in-class and first-in-category products. The current
development pipeline includes several therapeutic peptides of which three
programs are in clinical development, with potential for use in several medical
applications. Please visit our web site: www.pergamum.com.

About Karolinska Development AB
Karolinska Development aims to create value for patients, researchers, and
investors by developing innovations from world class science into products that
can be sold or out-licensed with high returns. The business model is to: SELECT
the most commercially attractive medical innovations; DEVELOP innovations to the
stage where the greatest return on investment can be achieved; and COMMERCIALIZE
the innovations through the sale of companies or out-licensing of products. An
exclusive deal flow agreement with Karolinska Institutet Innovations AB, along
with other cooperation agreements with leading universities, delivers a
continuous flow of innovations. Today, the portfolio consists of 35 projects, of
which 16 are in clinical development. For more information, please visit
www.karolinskadevelopment.com.

Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be
required to disclose the information provided herein pursuant to the Securities
Markets Act.