The target indication for our first candidate drug is atopic dermatitis (AD). This disease is a chronic and pruritic inflammation of the skin, which affects about 10-20% of children and 1-3% of adults worldwide. Moderate-to-severe AD has a profound effect on the quality of life. Intractable itching, skin damage, soreness, sleep loss all add to the burden of disease. AD is often triggered by bacterial and fungal infections.
More than 90% of all AD patients are colonized or infected by the Gram-positive bacterium Staphylococcus aureus, whereas only about 5% of healthy individuals harbor the bacterium. Infections with S. aureus play a significant role as it leads to an aggravated disease by producing superantigens that induce an inflammation of the skin. Thus, microorganisms are not only etiological factors but also act as agents responsible either for sustained disease activity or resistance to therapy.
Pre-clinical studies
In vitro and in vivo pre-clinical studies have been performed to select the candidate drug (CD) and a few backup compounds. The evaluation of the CD and other peptides has been made using in vitro tests based on a number of different cell-culture models, and in vivo models where the evaluation parameters are toxicity and biological effect.
Toxicological program
To support early clinical development of a peptide, a range of non-clinical safety studies are warranted and will be required by regulatory agencies. A proposal for a non-clinical safety program for DermaGen’s first CD was presented to the Swedish Medical Products Agency in 2007 and was accepted as a suitable package for initiating the clinical study. The CD has been evaluated by performing appropriate toxicological studies.
Clinical study
In the early development, the clinical studies of the CD will be performed in adults. The ongoing clinical study is a double-blinded study in which adult patients will be recruited after informed consent has been given, provided all inclusion and exclusion criteria are met.