DPK-060

The Challenge

Atopic dermatitis (AD, eczema) is a common disease in all of the developed pharmaceutical markets, afflicting 10-20 % of children and 1-3 % of adults. The disease is characterized by severe itching, skin lesions and dry skin. Some patients with severe AD are affected with recurrent conditions. Current treatments for moderate to severe AD are limited to conventional antibiotics. Because of safety issues and cost of treatment, these agents may only be used during shorts periods time or with regular treatment breaks.

Acute external otitis (EO) is a painful infection in the ear canal, usually lasting a short period of time. The incidence for acute EO in out-patient clinics in Europe and North America is around 1 %.

In both of these conditions, the weakened skin barrier makes patients susceptible to bacterial colonization. There is a major need for new categories of safe and effective antimicrobial treatments that by-pass the induction of antibiotics resistance.

Pergamum's Solution

DPK-060 is a new antimicrobial peptide that has the capacity to reduce the bacterial and fungal load in lesions of the skin, and to restore biologically the often-reduced expression of endogenous antimicrobial peptides and proteins in infected skin lesions of patients with AD and EO. It is structurally derived from the endogenous human protein kininogen, and optimized through modification of the amino acid sequence. DPK-060 interacts with microorganisms by attacking their membranes and causing the microorganisms to die rapidly. Development of classical bacterial resistance to antimicrobial host defense peptides is unlikely to occur. Consequently, it seems plausible that these peptides, which are components of the body’s innate immune system, can be used in long-term therapy. DPK-060 is formulated as an ointment for easy application on the skin (for AD) and as individually packaged doses of eardrops for easy application into the ear (for EO).

Competitive Advantages

Current treatment options for atopic dermatitis patients include steroids, immunomodulators and traditional antibiotics but they are associated with side effects and possible resistance development, neither of which have been seen so far in clinical studies with DPK-060. Furthermore, DPK-060 has a broad action spectrum and is both bactericidal (including S. aureus and multidrug-resistant S. aureus strains) and antifungal (including Candida and Malassezia).

The Market

The prevalence of atopic dermatitis has increased three to four-fold over the past 30 years, and more than 40 million people are suffering from atopic dermatitis in the major markets (US, the five largest EU markets (EU5), and Japan). External otitis is also a common condition, as it is estimated that at least 10% of the population in US and EU will develop at least one episode of EO during their lifetime¹.

The dermatology market is characterized by:

• Estimated annual sales of over EUR 12bn in total across all sectors in the US, EU5, and Japan
• Many of the current treatment options are either generic or private label versions of very similar products
• Sales of products used in atopic dermatitis therapy worldwide are estimated at over EUR 1.5bn in 2013