Phase I and Phase IIa proof-of-concept trial evaluating SB011 for the treatment of atopic dermatitis filed with regulatory agencies

Marburg, Germany, 01 October 2013
sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that two clinical trials evaluating SB011 for the treatment of atopic dermatitis were filed with regulatory agencies. This comprehensive clinical programme will generate important data regarding safety, tolerability, and efficacy of the drug candidate. SB011 is based on the same GATA-3-specific DNAzyme as SB010 and incorporates sterna biologicals’ proprietary dermal delivery system which is well-suited to deliver large molecules to relevant strata of the skin and effectively protects the DNAzyme against bacteria and harmful enzymes.

The Phase IIa clinical trial will seek to establish efficacy of SB011 in reducing modified local SCORAD in patients with atopic dermatitis compared to vehicle control. Approximately 26 patients will receive twice-daily treatments with SB011 or vehicle control on two defined lesions over two weeks. Key read-outs include modified local SCORAD, TEWL, subjective pruritus, subjective efficacy, as well as pharmacokinetic assessments.

Jonas Renz, Managing Director of sterna biologicals, commented: “We are pleased to have advanced our second drug candidate into the clinic. Our dedicated team and our partners have worked hard to achieve this milestone in our development and we would like to thank them for their contribution. Atopic dermatitis remains a disease area where patients are seeking alternatives to persistent corticosteroid or immunosuppressive medication, especially in more severe cases, due to the well-known side effects of these drugs.”

About SB010
Professor Jens Hohlfeld, principal investigator of the Phase Ib study in asthmatic patients, will focus on safety data obtained in patients and Dr Holger Garn will give an overview of the entire Phase I programme.

sterna biologicals’ drug candidate SB010 is an inhaled DNAzyme-based GATA-3 antagonist. GATA-3 is the master transcription factor in regulating Th2-driven inflammatory diseases such as asthma. 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 significantly reduced expression of these cytokines and was 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 (antisense), in case of SB010 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.

About asthma
Asthma is a major chronic inflammatory disease of the airways affecting an estimated 300 million people worldwide. In OECD countries, prevalence is around 10% and increasing, with greater than average prevalence amongst women, children, and the elderly.