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.”