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Successfull device feasibility studies with sterna biologicals asthma drug candidates SB010 enables select of optimal nebulizers for late-stage development and commercialization

  • 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
Marburg, Germany, September 05, 2018 – 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.
 
ABOUT ASTHMA
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) .
 
ABOUT SB010
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.
 
ABOUT STERNA BIOLOGICALS
Sterna biologicals GmbH & Co. KG is an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD), atopic dermatitis, and ulcerative colitis. By targeting transcription factors that play a central role in regulating Th1- and Th2-driven inflammatory mechanisms, the Company’s proprietary DNAzyme-based drug candidates can intervene with upstream inflammatory processes to address related diseases more effectively. Sterna has currently four programs in Phase 2 development.
 
For more information, please visit www.sterna-biologicals.com.
 
CONTACT
Christian Pangratz
Chief Executive Officer
 
sterna biologicals GmbH & Co. KG
Bismarckstrasse 7
35037 Marburg
 
This e-mail address is being protected from spambots. You need JavaScript enabled to view it This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Tel.: +49 (0)6421.98 30 05 0
 

sterna biologicals presents detailed results from successful phase 2a study with GATA-3 specific DNAzyme formulation SB012 in patients with ulcerative colitis

  • Comprehensive data set presented at Digestive Disease Week® in the U.S.
  • SB012 was safe and well tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis
  • Further support of GATA-3 antagonism as promising treatment approach for variety of chronic inflammatory diseases

Marburg, Germany, June 5, 2018 – sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that the full data set from the successful SECURE study (NCT 02129439), a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with the GATA-3 specific DNAzyme formulation SB012, was presented during an oral session on June 5th at Digestive Disease Week® in Washington, DC.

Read more: sterna biologicals presents detailed results from successful phase 2a study with GATA-3 specific DNAzyme formulation SB012 in patients with ulcerative colitis

 

sterna biologicals announces data with gata-3 specific dnazyme SB012 to be presented at Digestive Disease Week®

  • Further insights and data from Phase 2a trial in ulcerative colitis

Marburg, Germany, May 29, 2018 – Sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced today that further insights and data from a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its DNAzyme candidate SB012 will be presented at Digestive Disease Week® (DDW) in Washington, DC, June 2-5, 2018.

Read more: sterna biologicals announces data with gata-3 specific dnazyme SB012 to be presented at Digestive Disease Week®

 

sterna biologicals announces phase IIa data with SB010 published in Respiratory Research

  • 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

Marburg, Germany, April 19, 2018 – 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].

Read more: sterna biologicals announces phase IIa data with SB010 published in Respiratory Research

 

sterna biologicals reports phase 2a study data demonstrating efficacy of its gata 3 specific dnazyme formulation sb012 in patients with ulcerative colitis

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  • - Data presented at the 13th Congress of ECCO (European Crohn's and Colitis Organisation).
  • - SB012 was safe and well tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis. This represents a further validation of GATA-3-antagonism for the treatment of a variety of chronic inflammatory diseases.

Marburg, Germany, February 19, 2018 - sterna biologicals GmbH & Co. KG ("sterna"), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that positive data from the SECURE study (NCT 02129439), a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its GATA-3 specific DNAzyme formulation SB012, were presented at the 13th Congress of ECCO (European Crohn's and Colitis Organisation).

Read more: sterna biologicals reports phase 2a study data demonstrating efficacy of its gata 3 specific dnazyme formulation sb012 in patients with ulcerative colitis

 

sterna biologicals to participate in upcoming international conferences in H1 2018

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Marburg, Germany, 01 February 2018 - sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today announces its participation in the following key scientific and partnering conferences in the first half of 2018:

13th Congress of ECCO - European Crohn's and Colitis Organisation
Date: February 14-17, 2018 in Vienna, Austria

Read more: sterna biologicals to participate in upcoming international conferences in H1 2018

 

sterna biologicals appoints Christian Pangratz as Chief Executive Officer

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Marburg, Germany, 8 January 2018 – 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 appointed Christian M. Pangratz as Chief Executive Officer. He brings over 25 years of life sciences experience, notably in the areas of strategic planning, corporate and business development, alliance and project management, new product planning, marketing and sales.

Read more: sterna biologicals appoints Christian Pangratz as Chief Executive Officer

 

German Center for Lung Research (DZL) successfully completes investigator-initiated study evaluating SB010 in COPD patients

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  • Results presented today at the European Respiratory Society International Congress 2017 in Milan, Italy

Marburg, Germany, 11 September 2017 – sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that investigator Dr Timm Greulich from the Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University Marburg, will present key results of the recently completed Phase II clinical trial of SB010 at the European Respiratory Society (ERS) Congress held in Milan, Italy, 9 to 13 September 2017.

The German Center for Lung Research (DZL) conducted the investigator-initiated trial (EudraCT 2013-002332-24) using sterna biologicals' drug candidate SB010 and coordinated by the Coordinating Centre for Clinical Trials of the Philipps University Marburg (KKS).

SB010 is an inhaled first-in-class GATA-3 antagonist that demonstrated strong efficacy and safety in a previous Phase IIa clinical trial in asthmatic patients (Krug et al, 2015 and Krug et al, 2017).

Read more: German Center for Lung Research (DZL) successfully completes investigator-initiated study evaluating SB010 in COPD patients

 

sterna biologicals' co-founders receive Paul Martini Prize

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Marburg, Germany, 01 May 2017 – sterna biologicals GmbH & Co. KG ("sterna biologicals") is pleased to announce that two of its co-founders, Prof. Dr. Holger Garn and Prof. Dr. Harald Renz, were selected to receive this year's Paul Martini Prize. The prize is one of the most prestigious prizes in the field of medicine in Germany and is awarded by the Paul Martini Foundation for exceptional research achievements in the development of novel clinically relevant therapeutic approaches. The prize will be awarded today on the occasion of the 123rd Congress of the German Society for Internal Medicine in Mannheim.

Read more: sterna biologicals' co-founders receive Paul Martini Prize

 

sterna biologicals announces publication of pre-clinical data in Gastroenterology

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  • Paper summarizing role of GATA-3 in ulcerative colitis published in Gastroenterology
  • SECURE study of SB012 in patients with moderate to severe ulcerative colitis continues to progress (NCT02129439)

Marburg, Germany, 10 October 2016 – sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that detailed mechanistic investigations of the role of GATA-3 in ulcerative colitis, performed primarily by Prof Markus Neurath's group in Erlangen (Germany), were published in Gastroenterlogy (Popp et al, 2016).

The paper demonstrates that in contrast to patients with Crohn's disease, patients with severe ulcerative colitis (UC) are characterized by significantly elevated levels of GATA-3 which in turn correlates with high levels of pro-inflammatory cytokines interleukin (IL)-4, IL-5, IL-6, IL-9, IL-13, and IL-17, as well as levels of TNF. In a mouse model mimicking major features of UC, treatment with a GATA-3-specific DNAzyme resulted in marked reduction of GATA-3 expression paralleled by reduction in key pro-inflammatory cytokines. The pivotal role of GATA-3 in UC was further confirmed using mice genetically deficient of GATA-3. Mini-endoscopic investigations demonstrated significant reduction in inflammation to a level comparable to treatment with anti TNF therapeutics. In addition, therapeutic efficacy was also confirmed in TNF-independent or TNF-refractory settings.

Read more: sterna biologicals announces publication of pre-clinical data in Gastroenterology

 

sterna biologicals announces publication of SB010 Phase IIa results in the New England Journal of Medicine

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  • SB010 Phase IIa proof-of-concept results published in the New England Journal of Medicine
  • SB010 Phase I programme results published in the Journal of Allergy and Clinical Immunology
  • SB010 development programme comprising four completed clinical trials demonstrates excellent safety profile combined with efficacy comparable to monoclonal antibodies

Marburg, Germany, 17 May 2015 – sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that the full analysis of the recently completed Phase IIa proof-of-concept trial of SB010 was presented at the American Thoracic Society (ATS) 2015 International Conference in Denver, Colorado as part of session A2 entitled "The New England Journal of Medicine and JAMA. Discussion on the Edge: Reports of Recently Published Pulmonary Research." Concurrently, the paper was published in the New England Journal of Medicine (Krug et al., 2015).

Read more: sterna biologicals announces publication of SB010 Phase IIa results in the New England Journal of Medicine

 

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

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  • 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

Marburg, Germany, 3 Sept 2014 – 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.

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

 

sterna biologicals co-founder Prof Harald Renz to present key Phase IIa results at ATS

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Marburg, Germany, 14 May 2014 – sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that Prof Harald Renz will present key results of the recently completed Phase IIa clinical trial of SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma, at the upcoming American Thoracic Society (ATS) 2014 International Conference being held in San Diego, CA, 16 to 21 March.

Read more: sterna biologicals co-founder Prof Harald Renz to present key Phase IIa results at ATS

 

Introducing SB012 for the treatment of ulcerative colitis

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  • Phase IIa clinical trial of SB012 (the SECURE trial) approved by regulatory agencies

Marburg, Germany, 29 April 2014 – sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today a significant expansion of the company's clinical development pipeline. In addition to SB010 for the treatment of Th2-driven asthma and SB011 for the treatment of atopic dermatitis, SB012 joins these two promising drug candidates as a further GATA-3 antagonist in a major chronic inflammatory indication.

Read more: Introducing SB012 for the treatment of ulcerative colitis

 

Significant progress achieved in SB011 development programme

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  • Phase I trial of SB011 for the treatment of atopic dermatitis successfully completed

  • First patient enrolled in Phase IIa proof-of-concept trial

Marburg, Germany, 06 March 2014 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today successful completion of a Phase I study assessing the irritation potential of SB011 in healthy volunteers. SB011 is an emulsion containing 2% GATA-3-specific DNAzyme and employs sterna biologicals’ proprietary dermal delivery system which has demonstrated excellent protective and skin penetration enhancing effects in pre-clinical studies.

Read more: Significant progress achieved in SB011 development programme

 

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