Sweden-based Pergamum has dosed the first patient in a randomised Phase II study of DPK-060, designed for the treatment of patients with external otitis (swimmers ear).
DPK-060 is a novel anti-microbial peptide that has a broad spectrum action on bacteria including Staphylococcus aureus, multidrug resistant strains, Candida and Malassezia. The double-blind randomised placebo-controlled multicentre Phase II trial will enroll up to 70 patients with acute external otitis is intended to evaluate the efficacy, local tolerability and safety of DPK-060 ear drops in infections caused by bacterial or fungal pathogens.
Pergamum CEO Jonas Ekblom said DPK-060 is thought to have a positive impact in treating patients with external otitis. "Every year more than ten 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,'' he said.
Pergamum chairman of the board Torbjörn Bjerke said the company has developed a new class of broad-spectrum acting antimicrobial agents based on a peptide from the body's own defence system. "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," he added.
DPK-060 has shown positive data in a Phase II study in atopic dermatitis patients and has demonstrated the ability to treat many other dermatological conditions caused by the microorganisms. An earlier Phase I/II study also reported that DPK-060 successfully met primary the endpoint in treating skin infections.
Pergamum is a clinical-stage biopharmaceutical company, focused on developing state-of-the-art products, based on therapeutic peptides, for local application in dermatology, wound healing and anti-infection.