ESBATech’s Antibody Fragment ESBA105 Enters Phase IIa in Uveitis Study
New Clinical Advisory Board Established to Provide Industry Leadership and Ophthalmology Experience
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
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.
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.
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
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.