LEXINGTON, MA--(Marketwire - June 17, 2010) -
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."
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.
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 prostaglandins and beta blockers, 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 eye's trabecular meshwork grows increasingly clogged with protein debris, and the eye can become less responsive to these mechanisms. As such, a significant percentage of patients do not respond adequately to currently approved products, and up to 40% of patients are treated with a combination of products in the hope of achieving targeted reductions in IOP. 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 has significant potential as an IOP-lowering medicine, either as monotherapy or in combination with other glaucoma products, because it restores outflow of aqueous humor through the trabecular meshwork. As validation of its complementary mechanism to other glaucoma products, INO-8875 has shown substantial additivity of IOP-lowering efficacy when combined with the leading glaucoma product (Xalatan®, Pfizer) in a preclinical model. As a highly selective adenosine-1 receptor agonist, INO-8875 has a novel mechanism differentiating it from currently approved products and other candidates in development for glaucoma in that INO-8875 enhances a natural cellular signaling pathway to clear debris from the trabecular meshwork, resulting in improved outflow.
Inotek is a leader in the development of innovative drug candidates to address significant diseases of the eye, with a major focus on glaucoma. Inotek's lead product candidate INO-8875 is a potential first-in-class eye-drop product for glaucoma that significantly reduced intraocular pressure (IOP) in glaucoma subjects following single doses applied to the eye in a Phase 1/2 clinical trial. The Company believes INO-8875 will be a breakthrough treatment that can be used alone or combined with other IOP-lowering products because it increases the outflow of aqueous humor through the trabecular meshwork, the primary drainage system used by healthy elderly eyes to maintain normal IOP. The Company is also advancing 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.