LEXINGTON, MA, USA I March 10, 2014 I Inotek Pharmaceuticals Inc., a leader in the development of innovative products for the treatment of glaucoma, today announced the initiation of a Phase 2 clinical study of its lead product, trabodenoson, in combination with the most widely-prescribed glaucoma drug, the prostaglandin analog latanoprost (LAT), in patients with elevated intraocular pressure (IOP) that remains uncontrolled despite ongoing treatment with latanoprost.

The Phase 2 study is a randomized, double-masked, active-controlled, multicenter trial comparing trabodenoson plus LAT, to timolol (the active comparator) plus LAT, in 120 patients with ocular hypertension (OHT) or primary open-angle glaucoma (POAG). The study will measure the additive or synergistic IOP lowering effect of trabodenoson when combined with LAT, and will also evaluate the safety and tolerability of the combined treatment regimen. The total treatment time will be 3 months, during which the effect of trabodenoson will be evaluated following twice-a-day dosing (BID) and once-daily dosing (QD). Top line data is expected in the 4th quarter of 2014.

“Side effects limit the use of existing drug therapies for many patients, and the frequent dosing of non-prostaglandin drugs increases the burden of treatment on patients,” said Jonathan Myers MD, Associate Professor of Ophthalmology, Wills Eye Institute, Philadelphia, PA, and a member of the Trabodenoson Scientific Advisor Board. “Trabodenoson has been shown to lower IOP in patients with POAG or OHT and the data to date have indicated very good tolerability when given twice daily. It has also demonstrated the potential, to be confirmed in clinical trials, for once-daily dosing.”

“Trabodenoson has already been shown to significantly lower the IOP of non-human primates when added to all the classes of glaucoma drugs commonly used”, said Rudolf Baumgartner, Chief Medical Officer of Inotek Pharmaceuticals. “These results support the complementarity of trabodenoson’s novel mechanism of action, which we believe is acting on the most important outflow path – the trabecular meshwork. Our ongoing clinical study is specifically designed to investigate the synergistic effect of trabodenoson when given in combination with a prostaglandin. These data, together with the available data on trabodenoson’s efficacy as a single agent, will be critical in completing what we expect to be a very promising clinical profile for a new glaucoma agent.”

About Trabodenoson for Glaucoma

Trabodenoson is a drop-administered drug candidate in Phase 2 development for the treatment of glaucoma, a leading cause of blindness globally. It is broadly accepted that lowering intraocular pressure (IOP) in glaucoma patients is the only proven means of slowing the progression of vision loss. Trabodenoson is believed to reduce intra-ocular pressure by increasing aqueous fluid outflow via the eye’s trabecular meshwork, a novel mechanism of action that is significantly differentiated from currently approved products, as well as all others in development.

Current products for glaucoma, such as prostaglandins, lower IOP by either reducing the inflow of fluid in the eye or by increasing its drainage through a secondary outflow pathway in the eye – the uveoscleral pathway. However, none of these drugs safely and effectively target the trabecular meshwork, the primary outflow pathway where most fluid exits the eye. The trabecular meshwork comprises a pressure-sensitive mechanism through which healthy eyes maintain a normal, safe ocular pressure (IOP). As the eye ages and glaucoma advances, flow through the eye’s trabecular meshwork grows increasingly difficult. Trabodenoson has been shown to increase the natural metabolic activity of the trabecular meshwork, by up-regulating proteases found in the eye. These proteases are responsible for clearing out hydrolyzed proteins, which block flow through the trabecular meshwork, thus restoring the eye to a more normal, healthy state with greater potential for fluid outflow.

Many patients do not respond adequately to the current IOP-lowering products, and up to 40% of these patients are treated with a combination of products in the hope of achieving targeted reductions in IOP. As a result, there remains a significant unmet need for innovative glaucoma products that can complement the existing drugs by acting on the trabecular meshwork to provide improved IOP-lowering efficacy. In animal models, trabodenoson’s IOP-lowering activity has been shown to significantly enhance the effect of several existing glaucoma medications, including the prostaglandin latanoprost. Further, in the clinical trials to date, trabodenoson was found to be safe and well tolerated as a single agent, making it an ideal candidate for combination with marketed drugs such as latanoprost.

About Inotek

Inotek Pharmaceuticals is a privately held and funded biotechnology company focused on the discovery and development of innovative drugs to address serious diseases of the eye. Inotek scientists have identified a deep pipeline of drug candidates to ameliorate inflammation, ischemia-reperfusion injury, and oxidative stress, which are key targets for drugs to treat Glaucoma, Ocular Hypertension, Age-related Macular Degeneration and Retinal Neuropathies.

SOURCE: Inotek