Marburg, Germany, April 19, 2018
- Investigator initiated study sponsored and funded by DZL (German Center for Lung Research) in patients with moderate to severe eCOPD
- Primary endpoint and key secondary endpoints met
Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that data from a randomized, double-blind, placebo-controlled, multicenter phase IIa trial with SB010 in chronic obstructive pulmonary disease (COPD) patients with eosinophilic airway inflammation have been published in the peer-reviewed medical journal, Respiratory Research[i].
Preliminary results from this study were first presented at the European Respiratory Society International Congress in 2017.
The COPD trial enrolled a total of 23 patients with moderate to severe airflow obstruction and the presence of sputum eosinophilia, termed “eCOPD”. Nineteen of these patients completed treatment. The study achieved its primary endpoint, demonstrating the feasibility of conducting a larger phase II trial of SB010 in patients with moderate to severe, stable COPD. Moreover, SB010 significantly reduced the relative sputum eosinophil count by 58.8% (p=0.004) compared to 11% (p=0.38) in the placebo group in addition to standard therapy, including inhaled corticosteroids (ICS). SB010 was well tolerated, consistent with previous studies.
Christian Pangratz, CEO and Managing Director of sterna, said: “This is the first study of SB010 in COPD patients. The data, now also published in a renowned respiratory journal, are very encouraging and further support the potential utility of the GATA-3 pathway for the treatment of a variety of chronic inflammatory diseases, including but not limited to Th2-driven asthma, where sterna already demonstrated proof-of-concept with SB010. We are excited that SB010 demonstrated strong, clinically meaningful effects on the level of sputum eosinophils, also when added to ICS treatment, the key pharmacodynamic endpoint of this study. We look forward to the continued development of SB010 in COPD, an area where effective and well tolerated long-term therapies are very much needed, and would like to thank the DZL for the excellent collaboration.”
Chronic obstructive pulmonary disease (COPD) is a progressive disease of the airways that makes it hard to breathe and includes two main conditions - emphysema and chronic bronchitis. COPD is a major cause of disability, and it is the fourth leading cause of death in the United States. An estimated 16 million people in the US are diagnosed with COPD and over 13 million in the EU-5 countries suffer from the disease. Today, COPD has no cure, and the lung damage it causes cannot be reversed. Current treatments include bronchodilators, inhaled steroids and oxygen therapy, in addition to lifestyle changes.
Sterna biologicals’ drug candidate SB010 is an inhaled formulation of hgd40, a first-in-class GATA-3 antagonist.
GATA-3 is the master transcription factor regulating Th2-driven inflammatory diseases such as ulcerative colitis, atopic dermatitis, eCOPD and asthma. By inhibiting GATA-3, the expression of downstream cytokines, interleukin IL-4, IL-5, and IL-13, which cause inflammation, is down regulated. In pre-clinical and clinical development, hgd40 was found to be well tolerated with first signs of efficacy. DNAzymes are single-stranded DNA molecules comprising a central catalytic domain flanked by two binding domains. The binding domains attach to a specific sequence of targeted mRNA, such as GATA-3 mRNA in the case of hgd40. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant downstream cytokine expression.