Inotek Pharmaceuticals announced the completion of the active recruitment phase of the phase 2 dose-ranging trial of a fixed-dose combination (FDC) of trabodenoson and latanoprost for the treatment of glaucoma. Trabodenoson is a highly selective adenosine mimetic that lowers IOP by augmenting the natural function of the trabecular meshwork, the primary outflow pathway in the eye. Latanoprost, a prostaglandin analog, targets the secondary uveoscleral pathway and is the most commonly used drug for lowering IOP. Topline data from the FDC study are expected in July.
“We have completed active recruitment of glaucoma patients in our phase 2 FDC trial,” David P. Southwell, President and Chief Executive Officer of Inotek, said in the company news release. “This is an important milestone as we continue to believe our FDC program has the potential to address a larger market opportunity than monotherapy and provide patients with a novel treatment option that includes two complementary eye pressure lowering mechanisms. We look forward to reporting the topline results in July.”
Inotek also announced today that the company has secured a meeting with the FDA in the second quarter to discuss the trabodenoson monotherapy program.
“Inotek has submitted a briefing book to the FDA detailing the results of the completed MATrX-1 trial in order to seek their guidance on its continued development,” Rudolf Baumgartner, MD, Executive Vice President and Chief Medical Officer of Inotek, said in the news release. “We look forward to communicating the potential path forward for the monotherapy program once it is better defined.”
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 latanoprost 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 IOP lowering, while maintaining the favorable tolerability and safety profile observed to date. Latanoprost doses were selected based on efficacy and safety profiles which vary based on dose.
The trial enrolled approximately 200 patients (original enrollment was exceeded due to a lower than anticipated screen failure rate) 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.
For more information, please visit www.clinicaltrials.gov/ct2/show/NCT02829996.