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 has made tremendous progress over the past twelve months," said Dr Joachim Bille, Managing Director of the company. "We successfully completed three Phase I trials of SB010 and subsequently swiftly obtained regulatory clearances for this proof-of-concept trial. We are excited about working together with leading pulmonary institutions and look forward to clinical results in the first half of 2013."
sterna biologicals will also present the results of SB010's Phase I programme as well as further research at upcoming academic conferences: American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, TX (February 22-26) and American Thoracic Society International Conference (ATS) in Philadelphia, PA (May 17-22).
Dr. Joachim Bille, Managing Director, commented: “These excellent clinical results once again confirm the expected good safety profile of our DNAzyme-based drug candidates. The combination of local application, highly specific mechanism of action, and endogenous enzymatic activity make DNAzymes a promising therapeutic class.”
Sterna biologicals is also pleased to announce that it has filed a Phase IIa proof-of-concept trial with regulatory agencies. This trial will assess safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of SB010 in asthmatic patients. The trial will be conducted in seven study centres in Germany and is expected to complete in H1 2013.
Dr. Joachim Bille added: “We look forward to our upcoming proof-of-concept trial, which marks the first ever evaluation of inhaled DNAzymes for efficacy in patients.”
sterna biologicals’ drug candidate SB010 is an inhaled DNAzyme-based GATA-3 antagonist. GATA-3 is the master transcription factor in regulating Th2-driven inflammatory diseases such as asthma. It is generally accepted that GATA-3 is necessary and sufficient for the production of key cytokines interleukin (IL)-4, IL- 5, and IL-13, which cause inflammation. In pre-clinical development, SB010 significantly reduced expression of these cytokines and was safe and well-tolerated in toxicological studies with negligible side-effects. DNAzymes are single-stranded DNA molecules comprising a catalytic domain flanked by two binding domains. The binding domains attach to a specific sequence of targeted mRNA (antisense), in case of SB010 GATA-3 mRNA. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant cytokine expression.
Asthma is a major chronic inflammatory disease of the airways affecting an estimated 300 million people worldwide. In OECD countries, prevalence is around 10% and increasing, with greater than average prevalence amongst women, children, and the elderly.