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

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.

Introducing SB012 for the treatment of ulcerative colitis

Marburg, Germany, 29 April 2014

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

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.

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

Marburg, Germany, 21 February 2014

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

  • Outstanding safety profile confirmed

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. The study – a randomised, double-blind, parallel group, multi-centre clinical trial – was designed to establish efficacy of SB010 in improving lung function (FEV1) as measured by the area under the FEV1 curve (AUC) in the late phase asthmatic response after specific allergen challenge compared to placebo treatment.

Significant progress achieved in SB011 development programme

Marburg, Germany, 06 March 2014

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

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

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.

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

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. This comprehensive clinical programme will generate important data regarding safety, tolerability, and efficacy of the drug candidate. SB011 is based on the same GATA-3-specific DNAzyme as SB010 and incorporates sterna biologicals’ proprietary dermal delivery system which is well-suited to deliver large molecules to relevant strata of the skin and effectively protects the DNAzyme against bacteria and harmful enzymes.