Pergamum initiates Phase II trial with DPK‐060 in outer ear infections |
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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 Torbjörn Bjerke, CEO, Karolinska Development AB Download press release:
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