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.

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.

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

Marburg, Germany, 15 July 2013

  • No plasma accumulation effects evident in multiple-dose setting

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.

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

Marburg, Germany, 04 September 2013

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

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

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.