Date: 2012-12-21
Type of information:
phase: 2
Announcement: results
Company: Pergamum (Sweden)
Product: DPK-060
Action mechanism: 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.
Disease: external otitis (swimmers ear)
Therapeutic area: Infectious diseases
Country: Sweden
Trial details: 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.
Latest
news: * On December 21, 2012, Pergamum has announced that the primary end-point was met in the randomized Phase II trial of DPK-060 for treatment of acute external otitis. The completed study is a Phase II double-blind, randomized, placebo-controlled, multi-center trial in patients with acute external otitis. The primary objective of the trial was to assess local tolerability and safety of 2% DPK-060 ear drops in infections caused by bacterial or fungal pathogens. The trial enrolled 69 patients. After top-line analysis of the study data, it was concluded that DPK-060 is safe and tolerable for topical treatment in the outer auditory channel. In addition, secondary endpoints showed a complete cure in 85% - 94% (depending on which rating scale is utilized) of the patients after 10 days of treatment with DPK-060, and the difference compared to placebo was statistically significant.
Pergamum will start searching for a corporate partner for this program in 2013.
* On January 16, 2012, Pergamum has 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).
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.
