Uveitis study enters Phase IIa

March 4, 2009

ESBATech AG, a developer of antibody fragment therapeutics, has initiated a Phase IIa study in patients with acute anterior uveitis, designed to evaluate the safety, tolerability and clinical activity of topically applied ESBA105.

ESBATech AG, a developer of antibody fragment therapeutics, has initiated a Phase IIa study in patients with acute anterior uveitis, designed to evaluate the safety, tolerability and clinical activity of topically applied ESBA105.

ESBA105 is a single-chain antibody fragment directed against TNF-alpha, a mediator of inflammation. The Phase IIa trial will be conducted at several uveitis centres in Germany.

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.

The primary objectives 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 a recently announced Phase Ib/IIa study in patients undergoing cataract surgery, the company hopes 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 which will provide a broad range of ophthalmology experience and industry leadership.

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 added: "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."

Dr. Dominik Escher, can be contacted at escher@esbatech.comwww.esbatech.com