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ESBATech's Antibody Fragment Enters Phase Ib/IIa in Ophthalmology

Zurich, Switzerland - February 3, 2009

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

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.

# # #
Contacts:

Dr. Dominik Escher Lisa Rivero
CEO LaVoie Group
ESBATech AG +1-978-745-4200 X 106
+41-44-733 49 00 lrivero@lavoiegroup.com
escher@esbatech.com


This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.



 
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