sterna biologicals announces DZL to conduct investigator-initiated trial of SB010 in COPD

Marburg, Germany, 3 Sept 2014

  • German Center for Lung Research (DZL) to conduct investigator-initiated trial of SB010 in patients with eosinophilic COPD
  • Further data from Phase IIa trial of SB010 in asthmatic patients to be presented at the European Respiratory Society International Congress 2014 in Munich, Germany

sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that the German Center for Lung Research (DZL) will conduct an investigator-initiated trial of SB010 in patients with moderate to severe COPD characterised by airway eosinophilia. SB010 is a first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma that recently successfully completed Phase IIa development. In both clinical and pre-clinical development, SB010 has demonstrated strong anti-inflammatory effects including significant reduction in sputum eosinophils.

Prof Claus Vogelmeier, coordinating investigator of the DZL study group, commented: "recent clinical evidence indicates that approximately 10 to 25% of COPD patients have elevated eosinophil counts in sputum. Therapeutic strategies aimed at reducing eosinophils may therefore be beneficial in treating this subset of patients."

Jonas Renz, Managing Director, added: "sterna biologicals believes the future of care in complex diseases such as COPD lies in stratified therapy approaches in order to reflect phenotype heterogeneity. We are pleased to collaborate with academic research institutions in better understanding COPD and potentially opening new therapeutic options for patients."

sterna biologicals also announced today that Prof Norbert Krug will present further data from the recently completed Phase IIa trial of SB010 in asthma as part of Session 281 "Latest Insights in Airway Diseases" on 08 September 2014 (Hall B2-B43, 12:50 to 14:40). The late-breaking poster is entitled "Attenuation of allergen-induced asthmatic responses by inhaled GATA-3 specific DNAzyme."

About SB010
sterna biologicals' drug candidate SB010 is a first-in-class inhaled 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 a comprehensive Phase I clinical programme. SB010 demonstrated strong clinical effects in a Phase IIa proof-of-concept trial. 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 SB010 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.

About COPD
Chronic obstructive pulmonary disease (COPD) is a progressive disease of the airways characterised by emphysema and chronic bronchitis. Affected areas in the lung lose their gas exchange capacity due to air space wall destruction. A permanent state of inflammation further reduces lung function. The main cause of COPD is inhaled tobacco smoke. Approximately 5% of the global population is affected by COPD and it is the third leading cause of death in the United States.