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ESBATech's Antibody Fragment Enters Phase Ib/IIa in Ophthalmology
Date:2/3/2009

Topical Delivery of ESBA105, an Anti-TNF Alpha Antibody Fragment in Patients Undergoing Cataract Surgery

ZURICH, Switzerland, Feb. 3 /PRNewswire/ -- ESBATech AG, a leading developer of antibody fragment therapeutics, today announced the initiation of a Phase Ib/IIa study in patients undergoing cataract surgery. This study is designed to evaluate the safety, tolerability, and ocular pharmacokinetics (PK) of topically applied ESBA105 in patients, as well as assess the preventive activity on ocular inflammation resulting from the surgery. ESBA105 is a single-chain antibody fragment directed against TNF-alpha, a major mediator of inflammation. The study contains a randomized, double-blind, placebo controlled part and is being conducted as a monocentric trial in Switzerland.

The primary objectives of this study are to assess the local tolerability and safety of topical ESBA105 as well as to evaluate its intraocular levels and local biodistribution in the human eye. Secondary objectives include the assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.

Michael A. Thiel, M.D., Ph.D., principal investigator of this study and head of the Department of Ophthalmology at the Kantonsspital in Lucerne, Switzerland, commented, "Our team has previously published the basic feasibility of applying single-chain antibody fragments to the eye. With ESBA105, the people from ESBATech have introduced for the first time a single-chain antibody fragment that carries all necessary characteristics for clinical use. I look forward to the evaluation of ESBA105 in this human PK study."

Dominik Escher, Ph.D., Chief Executive Officer of ESBATech AG, added, "Progress has been lacking in the development of novel treatments for inflammatory ocular conditions. We are very pleased to advance our compound into clinical Phase Ib/IIa, only four months after successful completion of our Phase I trial. We are very confident that our topically available TNF-alpha inhibitor has a great potential in several ophthalmic indications. To our knowledge, ESBA105 is the most advanced topical antibody fragment in ophthalmology and this study will provide important information on pharmacokinetic and efficacy in the human eye."

Peter Lichtlen, M.D., Ph.D., Head of Clinical Development at ESBATech AG, commented, "We are very excited to report the initiation of this study. TNF-alpha is a well known and well characterized drug target for inflammatory conditions. However, the spectrum of potential indications in ophthalmology lies way beyond classical inflammatory diseases. In our preclinical studies that we have just published in IOVS, we were able to demonstrate excellent penetration of ESBA105, topically applied as eye drops to both anterior and posterior segment of the eye. In particular, topical administration of ESBA105 results in significant levels in the vitreous body which is of significant importance for many ocular diseases. In addition, only very low systemic exposure is observed, adding to the excellent safety profile that was confirmed in our recent healthy volunteer Phase I trial. As a component of the current human PK trial, we are going after all these pharmacological data as well. Demonstrating anticipated therapeutic concentrations of ESBATech's antibody fragments with eye drops represents a major step forward in treatments for important ocular conditions."

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 Cataract Surgery

A cataract is a clouding of the normally clear lens of the eye, usually caused by age-related changes in the lens structure. Cataracts are the leading cause of vision loss in adults that are 55 and older and are the leading cause of blindness worldwide. By age 65, about half of the human population has a cataract, and by age 75, almost everyone has a cataract. Surgery is the only effective treatment for cataracts and involves removing the cloudy lens and replacing it with an artificial lens. Over 90 percent of patients operated for cataract surgery gain a useful vision, but like any other surgery, problems may develop occasionally such as post-surgery inflammation. If poorly controlled, a condition called macular edema can be caused by inflammation, which when becoming chronic, leads to permanent damage to the retinal architecture and loss of visual acuity.

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. ESBATech's unique, scientific approach to stabilize monomeric, single-chain antibody fragments (scFvs) using its proprietary fully-human antibody fragment frameworks has elucidated the drug-like properties of these proprietary scFvs. 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 AG is a Zurich, Switzerland-based, privately held, clinical-stage biotechnology company concentrating in research, development and commercializing its fully human single-chain antibody fragments via local and topical administration. The company was the first to non-invasively deliver an ophthalmic biologic drug via eye drops elucidating a depot effect in the eye's vitreous. ESBATech's lead antibody fragment, ESBA105, is in clinical trials for several indications in ophthalmology but also in osteoarthritis.

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.


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