An Inotek Pharmaceuticals drug developed to treat glaucoma failed to beat a current treatment for the eye condition in a clinical trial, a second setback this year that puts the future of both the drug and the company in question.
Lexington, MA-based Inotek (NASDAQ: ITEK) released the early results from the Phase 2 clinical trial after the markets closed on Friday. The company has been testing its drug, trabodenoson, in combination with glaucoma drug latanoprost (Xalatan).
Glaucoma is an eye condition in which fluid buildup leads to an increase in pressure in the eye. The goal of Inotek’s Phase 2 trial, which enrolled 201 patients, was to show an improvement in this eye pressure in the two-month study. Inotek tested three different dose combinations of its drug and latanoprost.
Patients who received the drug combinations showed improvement compared to latanoprost at day 28. But that effect did not last. In the results released Friday, Inotek said by day 56, the eye pressure in patients who received latanoprost alone showed improvement by 1.3 millimeters of mercury, a measure of eye pressure. In patients who received combinations of the Inotek drug and latonoprost, the eye pressure remained unchanged.
Inotek reported no safety issues associated with its drug. The company says the most common side effect for the fixed-dose combination was urinary tract infection.
The clinical trial failure is the second this year for Inotek’s trabodenoson. In January, the company announced that its drug failed a Phase 3 study comparing the drug against a placebo. Inotek attributed that failure to a higher placebo response.
In a statement, Inotek CEO David Southwell said that Inotek is evaluating the future of trabodenoson, “as well as other strategic options.” The company has hired Perella Weinberg Partners to serve as a financial advisor during the review process. Inotek has scheduled a conference call for Monday to discuss the clinical trial results.