ESBATech Enters Phase I Osteoarthritis Clinical Study

January 9, 2009

(ChattahBox) — Because of the degenerative nature of osteoarthritis (OA), every year more than 130,000 knee replacement surgeries are performed in the U.S. alone. Similar numbers are seen in Europe and other major markets. 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 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.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 corticosteroids. These treatments, however, are restricted to pain management, but do not address cartilage degeneration. Blocking TNF alpha offers the opportunity to attack both aspects, managing pain and structure modification.

Dominik Escher, Ph.D., Chief Executive Officer of ESBATech AG, commented in a press release today, “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.”

About ESBATech AG

ESBATech AG is a Zurich, Switzerland-based, privately held drug discovery and development company focused on advancing antibody fragments for therapeutic applications. The Company applies its proprietary, fully human single-chain antibody frameworks to generate product candidates against targets of clinical relevance. ESBATech is focused on delivering high concentrations of its therapeutic antibody fragments to the targeted sites, in combination with extremely low systemic load, in order to achieve low risk of systemic drug reactions using topical and local delivery. The Company focuses on three franchises: ophthalmology, rheumatology and respiratory. In ophthalmology, the Company has successfully completed clinical Phase I development of ESBA105 administered topically via eye drops for inflammatory eye diseases. For more information about ESBATech, please visit, www.esbatech.com.


Comments

Got something to say? **Please Note** - Comments may be edited for clarity or obscenity, and all comments are published at the discretion of ChattahBox.com - Comments are the opinions of the individuals leaving them, and not of ChattahBox.com or its partners. - Please do not spam or submit comments that use copyright materials, hearsay or are based on reports where the supposed fact or quote is not a matter of public knowledge are also not permitted.