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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

 

Phase IIa proof-of-concept trial meets primary and secondary endpoints

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  • Significant improvement in lung function in both early and late phase asthmatic response

  • Outstanding safety profile confirmed

Marburg, Germany, 21 February 2014 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today top-line results of its recently completed phase IIa proof-ofconcept trial of SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2- driven asthma.

Read more: Phase IIa proof-of-concept trial meets primary and secondary endpoints

 

Phase I and Phase IIa proof-of-concept trial evaluating SB011 for the treatment of atopic dermatitis filed with regulatory agencies

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Marburg, Germany, 01 October 2013 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that two clinical trials evaluating SB011 for the treatment of atopic dermatitis were filed with regulatory agencies.

Read more: Phase I and Phase IIa proof-of-concept trial evaluating SB011 for the treatment of atopic dermatitis filed with regulatory agencies

 

Enrollment of Phase IIa proof-of-concept trial evaluating SB010 completed

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  • Results of Phase I programme to be presented at ERS 2013 in Barcelona

Marburg, Germany, 04 September 2013 – 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.

Read more: Enrollment of Phase IIa proof-of-concept trial evaluating SB010 completed

 

Bioavailability data of GATA-3-specific DNAzyme demonstrates long-lasting presence in airways of mice, rats, and dogs post inhalation

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  • No plasma accumulation effects evident in multiple-dose setting

Marburg, Germany, 15 July 2013 – Data published in Toxicology and Applied Pharmacology (Turowska et al., 2013) found that the DNAzyme used in sterna biologicals’ drug candidate SB010, a first-in-class inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, is well-suited for infrequent and convenient dosing approaches.

Read more: Bioavailability data of GATA-3-specific DNAzyme demonstrates long-lasting presence in airways of mice, rats, and dogs post inhalation

 

First patient enrolled in Phase IIa proof-of-concept trial of SB010, an inhaled GATA-3 antagonist for the treatment of Th2-driven asthma

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  • Multicentre, randomised, double-blind clinical trial to assess safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics of SB010 in 38 asthmatic
    patients

Marburg, Germany, 07 Januar 2013 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that the first patient was enrolled in a Phase IIa proof-ofconcept trial of SB010 (NCT01743768).

Read more: First patient enrolled in Phase IIa proof-of-concept trial of SB010, an inhaled GATA-3 antagonist for the treatment of Th2-driven asthma

 

sterna biologicals successfully completes Phase I development programme of SB010

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  • SB010 was safe and well-tolerated across all dose levels

  • Phase IIa proof-of-concept trial filed with regulatory agencies

Marburg, Germany, 11 September 2012 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that SB010, a DNAyzme-based GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, successfully completed its comprehensive Phase I development programme.

Read more: sterna biologicals successfully completes Phase I development programme of SB010

 

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