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ESBATech's Antibody Fragment Enters Phase I/IIa Clinical Development in Osteoarthritis with the Potential for Disease-Modifying Activity
Date:1/9/2009

ZURICH, Switzerland, Jan. 9/PRNewswire/ -- ESBATech AG, a leading developer of antibody fragment therapeutics, today announced the initiation of the Phase I/IIa clinical development of its anti-TNF alpha antibody fragment ESBA105 in osteoarthritis (OA). This double-blind, randomized, placebo-controlled Phase I/IIa clinical study is designed to investigate the safety, tolerability and efficacy on pain with ESBA105 applied locally via intra-articular administration to patients with severely painful OA of the knee. The multicenter study is initiated at various sites across Switzerland.

Dominik Escher, Ph.D., Chief Executive Officer of ESBATech AG, commented, "As of today, no disease-modifying osteoarthritis drug exists, which is the key unmet need. OA is being increasingly recognized as driven by episodes of local inflammation and thus, TNF alpha represents a highly promising target. TNF alpha is excessively generated in OA by chondrocytes, which are located within the cartilage. Thus, to achieve disease-modifying activity, it is expected that the drug needs to penetrate into the cartilage, which cannot be achieved by the currently marketed TNF inhibitors. With ESBA105, we observe a very efficient penetration into the cartilage. By that, inhibiting TNF alpha can address the major aspects of OA therapy: signs and symptoms and cartilage degeneration. If clinically successful, ESBA105 is uniquely positioned to fill the need to treat OA with a safe and effective local therapy. A disease-modifying drug would revolutionize the treatment of this debilitating disease."

TNF alpha is a cytokine and a key player in inflammation, and has been identified as a major contributor to pain (signs and symptoms) and cartilage degeneration (structure modification), the main clinical characteristics of OA. Current treatments for OA comprise mainly of non-steroidal anti-inflammatory drugs and intra-articular injections of hyaluronic acids and cortico
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