Pergamum Reports Positive Phase II Data from Clinical Trial in Outer Ear Infections
News Dec 24, 2012
Pergamum AB has announced that the primary end-point was met in the randomized Phase II trial of DPK-060 for treatment of acute external otitis. Karolinska Development AB is the majority owner of Pergamum AB.
"The study results announced today, clearly shows the potential for DPK-060 to play a significant role in the future treatment of outer ear infections. We estimate that more than 10 million people in the US, EU and Japan seek medical care for this disease, causing a considerable workload at otolaryngology departments", said Jonas Ekblom, CEO of Pergamum AB.
Ekblom continued, "There is a clear medical need to avoid rapidly increasing global prevalence of antibiotics resistance that limits the therapeutic value of conventional products.”
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.
External otitis, also frequently called swimmer’s ear is one of the most common ear, nose and throat infections treated in out-patient settings.
The clinical signs of the condition can range from mild inflammation and discomfort to life-threatening symptoms. DPK-060 is a novel anti-microbial peptide, which is unlikely to evoke antibiotic resistance.
“The data from this randomized study demonstrate that topical treatment with DPK-060 is safe and well tolerated. Furthermore, a sizable fraction of the patients that received DPK-060, demonstrated complete clinical cure after 10 days of treatment. As a consequence, we will start searching for a corporate partner for this program in 2013”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB.