ESBATech's Antibody Fragment ESBA105 Enters Phase IIa In Uveitis Study

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 25 Feb 2009 - 1:00 PDT

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ESBATech AG, a leading developer of antibody fragment therapeutics, announced the initiation of a Phase IIa study in patients with acute anterior uveitis. This study is designed to evaluate the safety, tolerability, and clinical activity of topically applied ESBA105 in uveitis patients. ESBA105 is a single-chain antibody fragment directed against TNF-alpha, a major mediator of inflammation. The Phase IIa trial is being conducted at several uveitis centers in Germany.

The primary objectives of this study are to assess the local tolerability and safety of topical ESBA105, as well as to evaluate the clinical activity of patients suffering from an attack of acute, unilateral anterior uveitis. With this Phase IIa study in uveitis and recently announced Phase Ib/IIa study in patients undergoing cataract surgery, the company continues to advance a pipeline of novel, antibody fragment therapeutics for local delivery in ocular diseases to ensure safe and convenient patient therapy.

In conjunction with the Phase IIa uveitis study, ESBATech has established a world-class Clinical Advisory Board dedicated to the advancement of the company's uveitis clinical development. Board members include:

-- Manfred Zierhut, M.D., Principal Investigator of ESBATech's Phase IIa uveitis study and Professor of Ophthalmology at the University of Tuebingen in Germany

-- James Rosenbaum, M.D., Professor of Ophthalmology, Head of Uveitis Clinic and Director of Inflammatory Research at the Oregon Health & Science and University Casey Eye Institute

-- Annabelle A. Okada, M.D., Associate Professor of Ophthalmology at the Kyorin University School of Medicine, Tokyo, Japan

-- Emmett T. Cunningham, Jr., M.D., Ph.D., M.P.H., Adjunct Professor of Ophthalmology at Stanford University, Stanford California. Prof. Cunningham is currently at Clarus Ventures and held several senior industry positions at Eyetech Pharmaceuticals, Inc. where he led the medical strategy team, and at Pfizer, Inc., where he was responsible for clinical development of therapeutic candidates in ophthalmology

-- Denis Wakefield, DSc, M.D., MBBS, FRACP, FRCPA, Professor and Associate Dean of Medicine at the University of New South Wales (UNSW)

-- Andrea Leonardi, M.D., Professor of Ophthalmology at Department of Neuroscience, Ophthalmology Unit and Faculty of Medicine at the University of Padua, Italy

Dominik Escher, Ph.D., Chief Executive Officer of ESBATech, commented, "The newly established uveitis Clinical Advisory Board, which consists of distinguished and well respected leaders in the ophthalmology field, will be of great strategic value as we advance ESBA105 through clinical development for uveitis. With our Advisory Board in place and the continued clinical progression in uveitis and other inflammatory ocular diseases, the company is well positioned to become the leader in delivering antibody fragments to both the anterior and posterior segment of the eye."

Peter Lichtlen, M.D., Ph.D., Head of Clinical Development at ESBATech, commented, "The start of this Phase IIa trial represents a major developmental and regulatory milestone. It has been a pleasure to design this study with the continuous support of such an esteemed panel of international uveitis experts that shares our view on the potential of this compound. As our previous work has shown, topically applied ESBA105 effectively penetrates into both the anterior and posterior segment of the eye, in combination with very low systemic exposure. Due to this unique biodistribution profile and the fact that ESBA105 is a potent TNF-alpha inhibitor, the compound holds significant promise for treatment of uveitis, as well as other ocular inflammatory disorders."

Principal Investigator and member of the Clinical Advisory Board, Prof. Manfred Zierhut commented, "ESBA105 represents a novel approach to treat uveitis. For the first time it seems possible to administer a biologic therapeutic to patients -- without systemic or intravitreal injections --- but topically with eye drops. I look forward to contributing to ESBATech's clinical advancement in uveitis as both the Principal Investigator of the Phase IIa study and a member of ESBATech's established Clinical Advisory Board."

ESBA105 is also being studied in other therapeutic indications such as osteoarthritis (OA). Earlier this year, ESBATech initiated a Phase I/IIa clinical study to explore clinical activity of ESBA105 in osteoarthritis of the knee.

About Uveitis

Uveitis refers to an inflammation of the uvea which includes the iris, ciliary body and choroid of the eye. Topical corticosteroids are the main agents for treatment of an acute anterior uveitis. Treatment is started immediately on diagnosis to reduce damage to the eye as well as improve symptoms of pain and photophobia. Steroids carry two key side effects, including raised intraocular pressure and cataract formation during long term treatment, in addition to local effects seen with topical therapy--e.g. delayed wound healing and aggravation of infection. In more severe cases, intraocular injections of steroids or immunosuppressive therapy are also used.

About ESBATech's Antibody Fragment Platform Technology

ESBATech is the first and only company to date that has successfully screened and characterized the entire human pool (1.5 million) of naturally occurring variable immunoglobulin (VH and VL) domains to select highly stable, soluble and monomeric single-chain antibody fragment frameworks applying its proprietary technology platform IMMUNA. ESBATech's unique, scientific approach using its fully-human antibody fragment frameworks has elucidated the drug-like properties of these proprietary single-chain antibody fragments. The company is advancing a pipeline of novel antibody fragment therapeutics for topical and/or local delivery, to ensure safe and convenient patient therapy.

About ESBATech AG

ESBATech is a Zurich, Switzerland-based, privately held, clinical stage biotechnology company concentrating in research, development and commercializing of its antibody fragments for therapeutic applications via local and topical administration. ESBATech applies its proprietary screening platform IMMUNA and its fully human single-chain antibody frameworks to generate product candidates against targets of clinical relevance. The company focuses on three franchises: ophthalmology, rheumatology and respiratory. In ophthalmology, ESBATech represents the most advanced company with topical delivery of an antibody fragment via eye drops being in clinical development.

Current venture investors include SV Life Sciences, Clarus Ventures, HBM BioVentures, HBM BioCapital, Novartis Venture Fund, BioMedinvest and VI Partners. For more information about ESBATech, please visit, http://www.esbatech.com.

ESBATech
http://www.esbatech.com

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