Inotek Pharmaceuticals announced the completion of the active recruitment phase of MATrX-1, the first pivotal phase 3 trial of trabodenoson for the treatment of glaucoma. Trabodenoson, the company’s lead clinical candidate, is a first-in-class selective adenosine A1 mimetic under investigation for reduction of IOP, which has been observed in phase 2 clinical trials to reduce IOP. Topline data from the MATrX-1 study are expected in December 2016.
“As anticipated, MATrX-1 has recruited on time, consistent with our fourth-quarter guidance for topline data,” Rudolf Baumgartner, MD, Executive Vice President and Chief Medical Officer, said in a company news release. “Trabodenoson has the potential to be a convenient, safe and innovative treatment option for patients suffering from glaucoma based on its targeted approach of restoring the natural pressure-regulating process in the eye to lower IOP, and we are looking forward to the results of this trial.”
About the MATrX-1 Phase 3 Trial
MATrX-1 is a phase 3 randomized, double-masked, placebo-controlled trial of trabodenoson in (~)335 patients suffering from primary open angle glaucoma (POAG) or ocular hypertension (OHT) that is designed to assess the efficacy, safety and tolerability of trabodenoson over 3 months of treatment. The primary endpoint is reduction of IOP as compared to the placebo treatment arm. The study includes three doses of trabodenoson: 3% (1000 mcg) once daily, 4.5% (1500 mcg) twice daily, and 6% (2000 mcg) once daily. In addition, the study contains a timolol 0.5% arm to validate the sensitivity of the patient population and will serve as an internal control. Enrollment criteria include patients with IOP greater than or equal to 24 mm Hg and less than or equal to 34 mm Hg, which represents the patients most likely to receive treatment for glaucoma or ocular hypertension.