Marburg, Germany, 04 September 2013
Results of Phase I programme to be presented at ERS 2013 in Barcelona
sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that the last patient was enrolled in a Phase IIa proof-ofconcept trial (NCT01743768) evaluating SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma. The study – a randomised, double-blind, parallel group, multi-centre clinical trial – seeks to establish efficacy of SB010 in improving lung function (FEV1) in the late phase asthmatic response after specific allergen challenge compared to placebo treatment.
Sufficient patients were enrolled across seven centres in Germany to obtain approximately 38 evaluable data sets (19 in SB010 treatment arm and 19 in placebo treatment arm) with respect to the primary endpoint, making the trial one of the largest allergen challenge trials of a novel drug candidate. Mild asthmatic patients were exposed to their respective specific allergen pre and post 28 day dosing in order to induce a biphasic lung function reaction which is indicative of Th2-driven asthma.
sterna biologicals also announced that results from the recently completed Phase I programme will be presented at ERS 2013 in Barcelona, the largest respiratory meeting worldwide, as part of session 466 “Emerging new targets for the treatment of respiratory diseases” on Wednesday, 11 September 2013 (room 3.9), in two presentations.
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.
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.