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Overview

sterna biologicals, a privately held biopharmaceutical company, is developing next generation antisense molecules, so-called DNAzymes, to treat chronic inflammatory diseases of lung, skin, and gut such as asthma, atopic dermatitis, ulcerative colitis, psoriasis, and COPD.

The company's lead compound SB010 for the treatment of moderate and severe Th2-driven asthma successfully completed Phase IIa develpment in 2014 and is currently being evaluated in a pilot Phase II study in patients with moderate to severe COPD characterised by eosinophilic inflammation of the airways.

SB010 represents a novel approach for the treatment of asthma by targeting GATA-3, the master transcription factor regulating Th2 cell differentiation and activation. Since Th2 cells release the cytokines IL‑4, IL-5, IL-9, and IL‑13, which in turn increase mucus production and cause hyper-reactivity in the airways, GATA-3 plays a central role in orchestrating the inflammatory response in asthma and other related diseases such as atopic dermatitis.

In mouse models, SB010 exhibits excellent anti-inflammatory effects. Further pre-clinical results demonstrate that the DNAzyme possesses favourable toxicological properties, enters cells in lung following inhalation, and is chemically stable and well-suited for aerosol delivery. GMP production is established.

Based on the same antisense approach, the company also developed a dermal drug delivery system for the treatment of atopic dermatitis (SB011) and an enema-based delivery for the gut (SB012). Both drug candaidates are currently in Phase IIa clinical trials.

The second arm of sterna biologicals' development programme focuses on the role of Tbet, the master transcription factor regulating Th1 cell differentiation and activation in a range of inflammatory diseases such as psoriasis (SB020) and COPD (SB021).

Headquartered in the Biomedizinisches Forschungszentrum (BMFZ), an affiliate of Marburg University, the company has made good progress since inception in 2006 and is looking forward to further clinical results.

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