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Direvo Biotech achieves major breakthrough by validating therapeutic, anti-inflammatory NBE® Protease in vivo

24 Oct 2005 - Direvo Biotech AG announced the successful in vivo validation of its NBE® Protease technology for the development of tailor-made proteases. The NBE® technology is the first approach to enable the engineering of proteases that specifically activate or inactivate any therapeutic target protein by cleavage. Thus, NBE® Proteases can efficiently and precisely eliminate proteins in the body that cause disease.
 
DBT-P2, Direvo's lead compound candidate, was developed using the NBE® technology. It inactivates human TNF-alpha in a highly specific manner. TNF-alpha plays a central role in inflammatory diseases such as rheumatoid arthritis. The anti-TNF-alpha protease displayed high specificity and anti-inflammatory efficacy both in vitro and in vivo. The in vivo studies were performed in an established and widely accepted mouse model, in which human TNF-alpha triggers arthritis-like symptoms. Further preclinical and clinical studies are planned. "The positive results of the anti-TNF-alpha protease confirm the general concept of target-specific proteases that can be directed against almost any therapeutically relevant protein target. The NBE® technology is thus well positioned to offer a clear alternative to monoclonal antibodies. In addition, it allows specific activation of proteins as a new therapeutic strategy," says Dr. Andre Koltermann, CEO and co-founder of Direvo. "These successful studies are a major milestone in establishing this highly innovative therapeutic approach. We are pleased to see our expectations confirmed in vivo," adds Dr. Ulrich Kettling, Chief Scientific Officer of Direvo. The animal studies were conducted in collaboration with the Institute of Pathology at the Clinic of the Friedrich Schiller University in Jena. "The data clearly demonstrate the anti-arthritic efficacy of the DBT-P2 NBE® Protease. The efficacy can be compared to the efficacy of monoclonal antibodies approved for rheumatoid arthritis. In addition, the NBE treatment group exhibited no side-effects on any of the examined organs", says study director Prof. Dr. Rolf Bräuer from the University Clinic, Jena, Germany.