Inotek Pharmaceuticals Corp., a leader in the development of innovative drug candidates to address significant diseases of the eye, today announced that it has initiated dosing in a multiple-dose Phase 2 clinical trial to evaluate the efficacy and safety of its novel eye-drop INO-8875 in patients with glaucoma. In an earlier Phase 1/2 single ocular dose clinical trial, INO-8875 was shown to significantly reduce intraocular pressure (IOP) in glaucoma patients. As a highly-selective adenosine-1 receptor agonist, INO-8875 reduces IOP by enhancing a natural mechanism for clearing protein material that clogs the major outflow pathway – the trabecular meshwork – as the eye with glaucoma ages.
“Currently available first-line treatment options for glaucoma do not adequately reduce IOP in up to 40% of glaucoma patients,” said Paul G. Howes, President and Chief Executive Officer of Inotek. “In addition, there exist no approved products for glaucoma that act on the major pathway for outflow – the trabecular meshwork. Based on our promising clinical and preclinical data, we believe INO-8875 has significant potential to be the first trabecular meshwork outflow enhancer to lower IOP in glaucoma, and with an excellent safety profile.”
“We believe INO-8875 is one of the most promising glaucoma product candidates in clinical development today,” said John Leaman, M.D., Principal at Devon Park Bioventures. “The Inotek team has made considerable progress advancing the candidate to date and we look forward to working with them as INO-8875 moves into later-stage clinical trials.”
Thomas K. Mundorf, M.D. of the Mundorf Eye Center in Charlotte, NC and investigator for the Phase 2 trial stated, “We are excited to evaluate the ability of INO-8875 to reduce IOP as a new class of agent for glaucoma, with its unique mechanism to improve outflow in the trabecular meshwork. As there is a clear unmet need for novel treatments that are both well tolerated and effective for lowering IOP in glaucoma patients, we believe INO-8875 is an exceptional candidate based on its profile to date.”
The Phase 2 trial is a randomized, double-blind, 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 includes multiple centers in the United States. For a more detailed description of the clinical trial protocol, please visit http://clinicaltrials.gov/ct2/show/NCT01123785.
In an earlier Phase 1/2 single ascending ocular dose study of 84 patients with primary open-angle glaucoma or ocular hypertension, INO-8875 was well tolerated up to the highest dose tested, with no serious adverse events or observed dose-limiting toxicities. While the trial was not powered to achieve statistical significance, statistically significant reductions in IOP compared to placebo were attained at the two highest doses of INO-8875 tested.