Inotek's phase 3 MATrX-1 trial of trabodenoson fails to meet primary endpoint

MATrX-1, a phase 3 trial of trabodenoson for the treatment of primary open-angle glaucoma or ocular hypertension, failed to achieve its primary endpoint of superiority in reduction of IOP compared with placebo at all time points, according to an Inotek Pharmaceuticals press release.

The randomized, double-masked, placebo-controlled trial assessed the safety, efficacy and tolerability of three doses of trabodenoson in 303 subjects. Patients’ IOP was measured on days 14, 28, 42 and 84 at four time points during each of these days: 8 a.m., 10 a.m., 12 p.m. and 4 p.m. Days 28, 42 and 84 were used for the primary endpoint trial.

Through the 3-month treatment period, trabodenoson did not show superiority to placebo at all 12 time points, the release said. The 8 a.m. time point in particular showed no statistical separation between placebo and trabodenoson, which Inotek attributed to an “unexpectedly high placebo response compared to that observed in phase 2.”

At days 84, 42 and 14, the 6%/2000 µg dose of trabodenoson was shown to be statistically superior to placebo with a daily IOP reduction of 4.25 mm Hg compared with 2.38 mm Hg for the placebo, according to the release.

“The safety, tolerability and low discontinuation rate in MATrX-1 continues to suggest that trabodenoson is an active molecule with a unique safety profile,” David P. Southwell, president and CEO of Inotek, said in the release. “Later this quarter, we expect to receive additional data beyond the top-line results reported [on Jan. 3]. Once we have the additional data, we will determine next steps in the trabodenoson monotherapy program.”