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.

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.

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.

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.

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.