News & EventsSTERNA BIOLOGICALS
Company news 2013
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.
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.
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.