Inotek Pharmaceuticals today announced trabodenoson did not achieve its primary endpoint of superiority in IOP reduction compared with placebo in patients with ocular hypertension and primary open-angle glaucoma.
Trabodenoson is a first-in-class therapy that mimics the adenosine-mediated control of IOP that occurs in a healthy eye. The drug selectively binds to the adenosine A1 receptor, leading to increased levels of matrix metalloproteinases (MMPs) in trabecular meshwork cells. This, in turn, results in remodeling of the extracellular matrix, restoring mechanosensitivity in the cells, and increases outflow through the trabecular meshwork.
The primary endpoint of the pivotal phase 3 trial was IOP reduction on days 28, 42 and 84 at 4 time points: 8 am, 10 am, noon and 4 pm. The drug did not demonstrate superiority at any of the 12 time points.
The company stated the results were, in part, due to “a placebo response that was 2 to 3 mmHg greater than that observed in Phase 2.”
However, company officials were optimistic about their results from the 6%/2000 mcg dose group, which was the highest concentration of trabodenoson tested in the trial. IOP within that group was statistically superior to placebo at days 84, 42, 14 and marginally superior at day 28.
The safety profile of trabodenoson was comparable to placebo.
“Looking ahead, 2017 is an important year for the trabodenoson development program,” said David P. Southwell, President and Chief Executive Officer of Inotek. “We will wait for the full results to better understand the behavior of the placebo arm. We look forward to the results of the fixed-dose combination (trabodenoson plus latanoprost) phase 2 trial, which is substantially enrolled and for which we expect to report top-line data mid-year.”