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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.

Prof Markus Neurath commented: "This very promising concept of inhibiting GATA-3 may be broadly applicable for the treatment of gastrointestinal diseases with a Th2 molecular signature, such as ulcerative colitis."


Jonas Renz, Managing Director of sterna biologicals, added: "Building on the strong data generated both pre-clinically and clinically with SB010, our inhaled first in class GATA-3 antagonist for the treatment of Th2-driven respiratory diseases (Krug et al., 2015), we are very excited that a central role of GATA-3 in ulcerative colitis is evidenced by this important publication. We look forward to the last patients enrolling in the SECURE study in the coming months."

References

Krug N, Hohlfeld J, Kirsten A, Kornmann O, Beeh K, Kappeler D, Korn S, Ignatenko S, Timmer W, Rogon C, Zeitvogel J, Nan Z, Bille J, Homburg U, Turowska A, Bachert C, Werfel T, Buhl R, Renz J, Garn H, Renz H. "Allergen-Induced Asthmatic Responses Modified by a GATA-3 Specific DNAzyme." New England Journal of Medicine. 2015.

Popp V, Gerlach K, Mott S, Turowska A, Garn H, Atreya R, Lehr H, Ho I, Renz H, Weigmann B, Neurath M. "Rectal Delivery of a DNAzyme That Specifically Blocks the Transcription Factor GATA3 Reduces Colitis in Mice." Gastroenterology. 2016 epub ahead of print.

 
About SB012
sterna biologicals' drug candidate SB012 is an enema-applied DNAzyme-based GATA-3 antagonist for the treatment of ulcerative colitis. The GATA-3-specific DNAzyme is also contained in the drug candidate SB010 for the treatment of Th2-driven respiratory diseases and SB011 for the treatment of atopic dermatitis. GATA-3 is the master transcription factor in regulating inflammatory diseases associated with the Th2 pathway such as ulcerative colitis, allergies and allergic 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 and SB012 significantly reduced expression of these cytokines and were safe and well-tolerated in toxicological studies with negligible side-effects. 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 SB012 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.

About ulcerative colitis
Ulcerative colitis is characterised by a continuous mucosal inflammation which predominantly affects the large intestine. Clinical symptoms include persistent diarrhoea with severe faecal urgency and often incontinence, rectal bleeding, abdominal cramping, weight loss, and general malaise. It is estimated that the disease affects approximately 2 million people in the US, Europe, and Japan.
 
About sterna biologicals
sterna biologicals GmbH & Co. KG is an innovative clinical stage biopharmaceutical company developing novel treatments for chronic inflammatory diseases such as asthma, atopic dermatitis, ulcerative colitis, psoriasis, and COPD. By targeting transcription factors that play a pivotal role in regulating underlying inflammatory mechanisms, the company's DNAzyme-based drug candidates can intervene at a very early stage in the disease formation process.

For more information, please visit www.sterna-biologicals.com or contact us:
Dr Joachim Bille
Managing Director
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Jonas Renz
Managing Director
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sterna biologicals GmbH & Co. KG
Bismarckstrasse 7
35037 Marburg
Tel.: +49.(0)6421.98 30 05 0

 

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

 

W/O/W emulsions effectively protect DNAzymes from degradation and enhance skin penetration

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  • Superior results achieved compared to other drug carrier systems such as W/O emulsions, microemulsions, and submicron emulsions

Marburg, Germany, 09 May 2012 – A paper published in the International Journal of Pharmaceutics (Schmidts et al., 2012) found that the formulation employed in sterna biologicals’ drug candidate SB011 is an excellent dermal delivery system for DNAzymes.

Read more: W/O/W emulsions effectively protect DNAzymes from degradation and enhance skin penetration

 

Experimental data demonstrate that GATA-3-specific DNAzymes do not lead to unspecific immune cell activation

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  • Results support favourable safety profile observed in toxicological studies and in recently completed first clinical trial of SB010

Marburg, Germany, 27 March 2012 – A paper published in Nucleic Acid Therapeutics (Dicke et al., 2012) found that the DNAzyme used in sterna biologicals’ drug candidate SB010, a novel inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, does not lead to unspecific immune cell activation.

Read more: Experimental data demonstrate that GATA-3-specific DNAzymes do not lead to unspecific immune cell activation

 

sterna biologicals completes first-in-man study of SB010

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  • sterna biologicals completes first-in-man study of SB010, an inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma
  • SB010 was safe and well-tolerated across all dose levels

Marburg, Germany, 27 February 2012 – sterna biologicals GmbH & Co. KG (“sterna biologicals”) is pleased to announce successful completion of a Phase I clinical trial of its novel inhaled GATA-3 antagonist SB010 for the treatment of moderate to severe Th2-driven asthma.

Read more: sterna biologicals completes first-in-man study of SB010

 

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