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

Marburg, Germany, 07 Januar 2013

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

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). The study’s primary endpoint is the improvement in lung function (FEV1) in the late asthmatic response after allergen challenge. SB010 (10mg dose) or placebo will be administered once daily in two parallel groups of 19 patients each over 28 treatment days. The study will be conducted in seven centres in Germany. Further trial-specific details are available at www.clinicaltrials.gov.

sterna biologicals successfully completes Phase I development programme of SB010

Marburg, Germany, 11 September 2012 

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

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

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.

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

Marburg, Germany, 27 March 2012 

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

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.

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

Marburg, Germany, 09 May 2012

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

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.

sterna biologicals completes first-in-man study of SB010

Marburg, Germany, 27 February 2012

  • 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

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.