Marburg, Germany, 06 March 2014
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Phase I trial of SB011 for the treatment of atopic dermatitis successfully completed
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First patient enrolled in Phase IIa proof-of-concept trial
sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today successful completion of a Phase I study assessing the irritation potential of SB011 in healthy volunteers. SB011 is an emulsion containing 2% GATA-3-specific DNAzyme and employs sterna biologicals’ proprietary dermal delivery system which has demonstrated excellent protective and skin penetration enhancing effects in pre-clinical studies.
20 subjects received treatment with SB011, SB011 vehicle, positive control, and negative control on four treatment areas of 100cm2 each. The IMPs were applied occlusively over six days to maximise skin contact. Primary endpoint was the change in cumulative irritiation index (CII) using a five-point erythema score. No significant differences between SB011, SB011 vehicle, and negative control were observed whereas the positive control CII was significantly increased compared to SB011 (p<0.0001).
sterna biological also announced that the first patient was enrolled in a Phase IIa proof-ofconcept trial of SB011 (NCT 02079688). The study’s primary endpoint is the change in local modified SCORAD. SB011 and SB011 vehicle will be applied twice daily on two lesional areas in 26 patients with mild to moderate atopic dermatitis (SCORAD between 20 and 50; modified local SCORAD ≥ 7) over 15 treatment days. The study is being conducted at the Medizinische Hochschule Hannover, Germany. Further trial-specific details are available at www.clinicaltrials.gov.
“We are very pleased with the good progress of our SB011 programme,” said Dr Joachim Bille, Managing Director. “In the five completed clinical trials of SB010 and SB011, our GATA-3-specific DNAzyme has been safe and well-tolerated. We look forward to the results of our ongoing proof-of-concept trial later in the year.”
About SB011
sterna biologicals’ drug candidate SB011 is a topically applied DNAzyme-based GATA-3 antagonist for the treatment of atopic dermatitis. The DNAzyme, which is also contained in the drug candidate SB010 for the treatment of Th2-driven asthma, is packaged in a novel proprietary emulsion which supports skin penetration and effectively protects the molecule from degradation. GATA-3 is the master transcription factor in regulating Th2-driven inflammatory diseases such as atopic dermatitis. It is generally accepted that GATA-3 is necessary and sufficient for the production of key cytokines interleukin (IL)-4, IL- 5, and IL- 13, which cause inflammation. In pre-clinical development, SB010 and SB011 significantly reduced expression of these cytokines and were safe and well-tolerated in toxicological studies with negligible side-effects. DNAzymes are single-stranded DNA molecules comprising a catalytic domain flanked by two binding domains. The binding domains attach to a specific sequence of targeted mRNA, in case of SB011 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.
About atopic dermatitis
Atopic dermatitis is a chronic inflammatory disease of the skin. The skin reacts to normally harmless irritants such as allergens and develops an immune response, often compounded by bacterial surface infections as the skin becomes dry or damaged. In developed countries, approximately 1 to 3% of adults and 5 to 20% of children are affected by atopic dermatitis.