Inotek Pharmaceuticals to Expand Phase 2 Clinical Trial in Glaucoma Based on Promising Preliminary Results

--Current investors provide additional funding to support study expansion--

LEXINGTON, Mass.--(BUSINESS WIRE)-- Inotek Pharmaceuticals Corp., a leader in the development of innovative medicines to address significant diseases of the eye, today announced that the Company has successfully completed the first two of three stages of a multiple-dose Phase 2b clinical trial of its novel eye-drop candidate, INO-8875, in patients with glaucoma or ocular hypertension. Based on the achievement of this milestone, Inotek’s investors have committed the final tranche of their previous $20 million funding round and have committed an additional $3.7 million to expand the final portion of the ongoing clinical trial by increasing the number of subjects and the duration of treatment in the final phase.

“INO-8875 continues to make significant progress in glaucoma clinical trials and importantly, to date, has demonstrated a very favorable safety profile,” said Paul G. Howes, President and Chief Executive Officer of Inotek. “We believe that expanding the final stage of the Phase 2b study will produce a robust data package to support preparation for late-stage clinical trials and ongoing partnering discussions. We’re pleased our current investors have responded to our success with additional financial support.”

“INO-8875 improves outflow in the trabecular meshwork—a highly-promising, new mechanism to reduce intraocular pressure in glaucoma,” commented Jerry Karabelas, Ph.D., Partner at Care Capital. “Inotek continues to demonstrate the potential of this candidate and is in line to be the first company in many years to market a truly novel approach to treating glaucoma.”

The Phase 2b trial is a multi-dose, randomized, double-masked, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and efficacy of INO-8875 delivered as an eye-drop formulation in patients with primary open-angle glaucoma or ocular hypertension. The trial is being conducted at multiple centers in the United States. For a more detailed description of the clinical trial protocol, please visit http://clinicaltrials.gov/ct2/show/NCT01123785.

About INO-8875 for Glaucoma

Glaucoma is a leading cause of blindness globally and it is broadly accepted that lowering intraocular pressure (IOP) in glaucoma patients is the only clinically reliable means of slowing the progression of vision loss. Current products for glaucoma, such as beta blockers and prostaglandins, lower IOP by reducing inflow of fluid in the eye or increasing its drainage through a secondary pathway in the eye – the uveoscleral pathway. As glaucoma advances with age, the natural drainage path via the eye’s trabecular meshwork grows increasingly clogged and, not surprisingly, a significant percentage of patients do not respond adequately to the currently approved products which act elsewhere. In fact up to 40% of patients must be treated with a combination of products in the hope of achieving target IOPs and stemming vision loss. As a result, there remains an unmet need for innovative glaucoma products acting on the trabecular meshwork to provide improved IOP-lowering efficacy.

The Company believes INO-8875, a highly selective adenosine-1 receptor agonist, has significant potential, either as monotherapy or in combination with other glaucoma products, because it uniquely restores the outflow of aqueous humor through the trabecular meshwork, resulting in lower IOP. INO-8875 has also shown substantial additive IOP-lowering efficacy when combined with the leading glaucoma product (Xalatan®, Pfizer) in a preclinical model, suggesting that its mechanism may complement the mechanism of other glaucoma products.

About Inotek

Inotek is a leader in the development of innovative drug candidates to address significant diseases of the eye, with a major focus on glaucoma. The Company also has a broad pipeline of PARP inhibitors and SOD mimetics that alleviate oxidative injury and inflammation, which it believes may address significant unmet medical needs in retinal diseases, such as the dry form of age-related macular degeneration (dry AMD). The Company is located in Lexington, MA. For further information on Inotek, please visit www.inotekcorp.com.



CONTACT:

MacDougall Biomedical Communications
Sarah Cavanaugh/Jacqui Miller
781-235-3060
[email protected] or [email protected]

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Optical  Pharmaceutical  Research  Science

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