— INO-8875 represents new mechanism of action to treat glaucoma by targeting the trabecular meshwork —
LEXINGTON Mass., — June 25, 2009 — Inotek Pharmaceuticals today announced positive top-line results from a Phase 1/2 randomized, double-blind, placebo-controlled clinical trial of the Company’s lead candidate, INO-8875, in patients with glaucoma. Treatment with INO-8875 was well tolerated and resulted in a statistically significant reduction in intraocular pressure (IOP). Elevated IOP can be a risk factor in the development and progression of optic nerve changes and vision loss associated with glaucoma and is thought to be a causal factor in the neuropathology of the disease. INO-8875 represents a new approach to treating glaucoma patients by increasing the outflow of ocular fluid via the trabecular meshwork, the main pathway used by healthy eyes to maintain normal IOP.
“The glaucoma market has not seen the introduction of a therapeutic with a new mechanistic approach for over a decade,” said Paul G. Howes, President and Chief Executive Officer of Inotek. “We believe INO-8875 is an important investigational agent that holds great potential for the treatment of glaucoma and other indications marked by elevated IOP. We intend to continue our Phase 2 program with INO-8875 in glaucoma in 2010, while also continuing to advance our pipeline which includes novel therapeutic approaches to other serious ophthalmic diseases, including age-related macular degeneration and diabetic retinopathy.”
The Phase 1/2 single ascending dose study, involving 84 subjects with primary open-angle glaucoma or ocular hypertension, was designed to evaluate the safety, tolerability, and efficacy of INO-8875 administered topically to the eye. INO-8875 was well tolerated up to the highest dose tested, with no evidence of serious adverse events and no observed dose-limiting toxicities. INO-8875 demonstrated linear, dose-proportional pharmacokinetics, with minimal systemic absorption.
IOP was measured at multiple time points during the treatment period. Dose-dependent reductions in IOP were observed with INO-8875 treatment. While the trial was not powered to achieve statistical significance, and none was expected given the sample size, statistically significant reductions in IOP compared to placebo were attained at the two highest doses of INO-8875 tested. Full results from the study will be presented at a future medical meeting.
“These data suggest that INO-8875 has the potential to become a meaningful therapeutic for patients with glaucoma,” said Rudolf Baumgartner, M.D., Chief Medical Officer of Inotek. “By leveraging the effects of INO-8875, physicians may be able to add a new mechanism of action for lowering IOP to their treatment armamentarium to reach individualized target IOP levels and reduce vision loss associated with glaucoma.”
Inotek is a clinical-stage pharmaceutical company developing ophthalmic therapies with novel mechanisms of action to address significant diseases of the eye. The Company has an emerging pipeline of drug candidates targeting a broad range of ophthalmic diseases, including glaucoma, age-related macular degeneration and diabetic retinopathy.
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