Marburg, Germany, September 05, 2018
- Feasibility studies show excellent data with SB010 across a selection of high efficiency hand-held nebulizers
- Company well positioned to advance SB010 into late-stage clinical development
Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced today that the Company has successfully completed in vitro device feasibility studies with its asthma drug candidate, SB010. These studies support the selection of the most efficient and user-friendly device options for late-stage development and commercialization of SB010.
Feasibility studies evaluated a selection of nebulizers regarding their compatibility with SB010`s formulation in terms of nebulization characteristics such as aerodynamic particle size distribution and delivered dose with the goal of identifying the optimal hand-held nebulizer systems to use in late-stage clinical studies and ultimately, on the market.
“The phase IIa data with SB010 in asthma patients were extremely encouraging. SB010 is one of the very few drug candidates to have shown significant clinical effects in both early phase and late phase asthmatic response, particularly in patients with high blood eosinophil levels, supporting sterna’s highly differentiated approach to comprehensive and specific Th2 pathway downregulation via the inhibition of GATA-3,” commented Christian Pangratz, CEO and Managing Director of sterna. “These promising data, in combination with the optimal nebulizers identified in our feasibility studies, position us well to bring SB010 into late-stage clinical development. We look forward to continuing the development of SB010 in patients with moderate to severe asthma, an indication where effective and well tolerated treatments are very much needed.
Asthma is a major chronic airway inflammatory disease that makes it hard to breathe. With a World Health Organization (WHO) estimate of 235 million people currently suffering from asthma, there is clearly an unmet medical need (1). Moreover, trends suggest an increase in both the prevalence and morbidity of asthma, especially in children younger than 6 years.
Highlighting the high prevalence, severity and economic effects of asthma, in 2014 it was estimated by the Global Asthma Network Worldwide that asthma accounts for about 1% of all disability-adjusted life-years (DALYs) lost (2) .
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.
PHASE IIa RESULTS
In the randomized, double-blind, parallel group, multi-center phase IIa trial, SB010 demonstrated strong efficacy and excellent safety and, compared to placebo, led to a significant improvement in lung function in both early (immediate reaction post allergenic exposure, EAR) and late phase (3-8 hours post allergic exposure, LAR) asthmatic response. SB010 attenuated the decline in mean LAR under the FEV curve (AUC) by 34% (decline in median LAR AUC attenuated by 48%) compared to a 1% worsening in mean lung function in the placebo group (p=0.02). SB010 also attenuated the decline in mean EAR AUC by 11% (decline in median EAR AUC attenuated by 15%) compared to a 10% worsening in mean lung function in the placebo group (p=0.03). SB010 was safe and well tolerated. No serious treatment emergent adverse events occurred in either treatment group.