Inotek Pharmaceuticals announced the initiation of a phase 2 dose-ranging trial of a fixed-dose combination of trabodenoson and latanoprost for the treatment of glaucoma.
Trabodenoson, the company’s lead clinical candidate, is a first-in-class, highly selective adenosine A1 mimetic which has been observed in phase 2 clinical trials to reduce IOP. Latanoprost is a prostaglandin analog and the most commonly used drug for lowering IOP. Approximately 50% of glaucoma patients that receive a prostaglandin require a second, adjunctive therapy to achieve sufficient IOP-lowering. However, no combination product with a prostaglandin has been approved in the United States.
“The phase 2 trial of trabodenoson and latanoprost as a fixed-dose combination in a single eye drop substantially broadens the scope of Inotek’s trabodenoson development program,” Rudolf Baumgartner, MD, Chief Medical Officer of Inotek, said in a company news release. “Trabodenoson is designed to restore the eye’s natural pressure by increasing aqueous humor outflow via the trabecular meshwork, the primary outflow apparatus of the eye and a site of pathology in glaucoma. Existing therapies, including prostaglandin analogs, primarily regulate eye pressure through other mechanisms such as the uveoscleral or secondary pathway. We believe that a fixed-dose combination of trabodenoson with latanoprost has the potential to provide patients and physicians with a novel treatment option that offers the convenience of a single daily drop, with two complementary eye pressure lowering mechanisms, and an optimized safety and efficacy profile.”
About the Phase 2 Fixed-dose Combination Study of Trabodenoson and Latanoprost
The randomized, double-masked, phase 2 dose-ranging trial will assess the overall benefit/risk profile of binocular topical application of different daily doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) for 8 weeks in patients with ocular hypertension or primary open-angle glaucoma.
Three treatment combinations of trabodenoson and latanaprost will be investigated as well as two separate concentrations of latanoprost alone. The treatments are: trabodenoson 6%/latanoprost 0.005%, trabodenoson 3%/latanoprost 0.005%; trabodenoson 6%/latanoprost 0.0025%; latanoprost 0.005%; and latanoprost 0.0025%. Trabodenoson doses were selected to optimize intraocular pressure lowering, while maintaining the excellent tolerability and safety profile observed to date. Latanoprost doses were selected based on efficacy and safety profiles which vary based on dose.
The trial will enroll approximately 165 patients with an IOP greater than or equal to 25 mmHg and less than or equal to 34 mmHg; which represents the patients most likely to receive treatment for glaucoma or ocular hypertension. Following a placebo run-in period, treatment will be administered to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of morning and 4 weeks of evening dosing in a masked manner. Morning versus evening dosing is masked using placebo in addition to the active drug product.
For more information, visit www.clinicaltrials.gov/ct2/show/NCT02829996.