Fraunhofer ITEM: Successful Testing of New Drug for Allergic Asthma

A novel therapeutic principle is aimed at controlling the airway inflammation in allergic asthma, to mitigate the course of the disease. With its comprehensive expertise, Fraunhofer ITEM successfully performed toxicology testing of the novel DNAzyme-based drug developed by sterna biologicals GmbH & Co. KG and also part of the clinical trials. The results of the proof-of-concept study in man have now been published in the renowned “New England Journal of Medicine”.

Asthma is a highly prevalent airway disease, affecting an estimated 300 million people worldwide. Asthmatics suffer not only from the disease itself, but also from its wide-ranging consequences. The therapeutic options for severe asthma to date are little satisfactory and require a new therapeutic principle. This is what sterna biologicals has developed with the new drug “SB010”. It is based on inhibiting the transcription factor GATA-3 by a so-called DNAzyme – a synthetic DNA molecule with enzymatic action for inhaled administration. It binds to the transcription factor that triggers the inflammatory response and thus the typical asthma symptoms, inactivating it by enzymatic cleavage.

The Fraunhofer ITEM has accompanied development of this first-in-class antagonist with its expertise, from scientific advice and the required toxicity tests (in cooperation with Nycomed GmbH) to clinical trials of phases Ib and IIa. The latter, i.e. the proof-of-concept study, was conducted as a multi-center study in seven German centers under the scientific direction of Professor Norbert Krug, Fraunhofer ITEM Medical Director.

In the randomized, double-blind, parallel-group, multi-center trial, efficacy of the new therapeutic agent was tested. Treatment with “SB010” over 28 days significantly improved lung function after specific allergen challenge as compared to placebo. “SB010” furthermore proved to be safe and well tolerated. The results of this study were presented during this year’s International Conference of the American Thoracic Society in Denver, USA.

“Recent research indicates that approximately 50 percent of all asthmatics suffer from allergic asthma. This type of asthma is Th2-driven across all levels of disease severity. Therefore, developing novel therapeutics specifically for this group of patients holds great promise, in particular of drugs for inhaled delivery. Further clinical trials with ‘SB010’ in a larger cohort of asthmatics are thus warranted,” explains Krug.

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