Pergamum initiates Phase II trial with DPK-060 in outer ear infections
STOCKHOLM, SWEDEN - January 16, 2012. Pergamum AB today announced that the first patient has been dosed in a randomized Phase II study of DPK-060 for the treatment of patients with external otitis (swimmers ear).
"Every year more than 10 million people world-wide seek medical care for treatment of infections in the outer ear. There is a significant medical need to avoid rapidly increasing global prevalence of antibiotics resistance that limits the therapeutic value of conventional products, and we think that we can meet this need with DPK-060", says Jonas Ekblom, CEO of Pergamum
Pergamum's Phase II-study is a double-blind, randomized, placebo-controlled, multi-center trial in patients with acute external otitis. The objectives of the trial are to assess the efficacy, local tolerability and safety of DPK-060 ear drops in infections caused by bacterial or fungal pathogens. The trial is expected to enroll approximately 70 patients. The principal investigator for this trial is Dr. Pekka Koskinen, who is Managing Director at the Center för Läkemedelsstudier, Malmö, Sweden.
DPK-060 is a novel anti-microbial peptide which is structurally derived from the endogenous human protein kininogen. It has a broad-spectrum action on bacteria such as Staphylococcus aureus, including multidrug-resistant strains, as well as fungi such as Candida and Malassezia. DPK-060 has shown positive data in a clinical Phase II study in atopic dermatitis and has the potential to treat many other dermatological conditions where these microorganisms are a major problem.
"Pergamum has developed a new class of broad-spectrum-acting antimicrobial agents based on a peptide from the body's own defence system", says Torbjörn Bjerke, Chairman of the board in Pergamum and CEO of Karolinska Development AB. "The results of this clinical study is an important step towards a potential new prescription product for topical application that could change the treatment of skin infections, not only in the field of external otitis, but also in several other infections under investigation by Pergamum."
For further information, please contact:
Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)70 551 66 60, 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
TO THE EDITORS
About Pergamum AB
Pergamum is a biopharmaceutical company specialized in the development of therapeutic peptides for treatment of skin infections and wounds. Within Pergamum, companies and projects are managed as fully integrated operating units with access to a core team of experienced professionals within drug development and business management. This model provides Pergamum with an attractive diversified product pipeline while minimizing development cost and time-to-market and mitigating risk. Three programs are currently in clinical phase. www.pergamum.com
About Karolinska Development AB
Karolinska Development aims to create value for investors, patients, and researchers 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 Nordic universities, delivers a continuous flow of innovations. Today, the portfolio consists of 34 projects, of which 14 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.