Strategy

Treatment of type 2 inflammation driven diseases at their route cause

sterna biologicals aims to causatively interfere at a very early stage with the central type 2 inflammatory processes by targeting the master transcription factor GATA-3. Using a unique antisense molecule – a DNAzyme - sterna is the only company successfully making GATA-3 druggable and has demonstrated that GATA-3 downregulation could provide for a truly novel, first-in-class broad-spectrum anti-inflammatory breakthrough therapy.

Leveraging the result of a decade of research into DNAzymes and immunology Sterna has two lead programs ready for Phase IIb clinical development with fundamental advantages compared to existing forms of therapy and seeks to provide medical relief to so far inadequately addressed patient populations suffering from type 2-driven inflammatory diseases.

One of the Company’s two lead programs is SB010 for moderate and severe type 2-driven asthma. A range of publications in some of the world’s leading medical journals demonstrate that GATA-3 occupies a key position in the pathology of asthma. sterna discovered that its GATA-3 specific lead molecule administered in a liquid inhaled formulation proved to be superior to other forms of therapy in vitro. In vivo, it showed significant anti-inflammatory activities in pre-clinical models as well as in Phase I and Phase IIa clinical trials, leading to a significant improvement in lung function in both early and late phase asthmatic response. sterna’s second lead program SB012 for patients with moderate to severe ulcerative colitis was found to be safe and well-tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis.

Both programs leverage sterna’s proprietary and patent-protected active pharmaceutical ingredient hgd40, a DNAzyme and first-in-class GATA-3 specific antagonist. Additionally, the Company has a pipeline of hgd-40 based programs in COPD and atopic dermatitis.

The highly attractive characteristics of DNAzymes and therewith of hgd40 are

  • high specificity (i.e. very limited to no off-target effects)
  • gymnotic delivery (i.e. no chemical modification and/or transfection reagents required for intracellular delivery)
  • direct mRNA degradation, continuous enzymatic activity (i.e. one DNAzyme can cleave many mRNAs),
  • fully synthetic manufacturing (i.e. highly economical production process)
  • local administration (i.e. no systemic side effects)

as well as highly favourable safety/efficacy profile make DNAzymes the ideal drug candidates to tackle inflammation, the worldwide chronic burden and killer No 1.