CHICAGO—Inotek is committed to “transforming glaucoma treatments,” David Southwell, president and CEO, said here during the Ophthalmology Innovation Summit. Glaucoma is a $5.6 billion worldwide market with well-recognized low compliance among patients on topical therapies.
Inotek’s trabodenoson is a novel adenosine mimetic that stimulates a natural pathway; early studies indicated no dose-related side effects in a monotherapy trial and a clear dose response with good ocular and systemic safety in a Phase II trial.
“Trabodenoson showed an ability to dose QD or BID, and an additive efficacy to prostaglandins,” Southwell said. The company’s first Phase III monotherapy study (MATrX-1) is evaluating both QD and BID against placebo, with results expected before year-end.
Half of the US glaucoma market is dominated by prostaglandins, with an average 6 to 8 mm Hg drop in pressure levels from baseline; the remaining half is a combination of adjunctive agents that include beta blockers, alpha agonists, and carbonic anhydrate inhibitors.
Trabodenoson, however, binds to the A1 receptors on the trabecular meshwork and upregulates matrix metalloproteinase-2, “digesting the extracellular matrix proteins that clog the trabecular meshwork,” Southwell explained.
A Phase II study found trabodenoson 500 mcg statistically lowered intraocular pressure (IOP) at all time points on Day 28, with low and unchanged hyperemia scores across all doses.
MATrX-1 enrolled about 300 patients for 12-week treatment; entry IOP was at least 24 mm Hg. The study is evaluating three doses of trabodenoson: 1000 mcg QD, 2000 mcg QD, and 1500 mcg BID, and comparing outcomes with timolol 0.5% BID and placebo.
The first fixed-dose combination therapy trial began in July 2016. This Phase II trial of trabodenoson with latanoprost has enrolled about 165 subjects with either ocular hypertension or primary open-angle glaucoma with baseline IOPs between 25 mm Hg and 34 mm Hg. Data readout is expected during the second half of 2017.
David P. Southwell
Mr. Southwell has been President and CEO since August 2014, and led Inotek through its IPO and secondary financing. He was previously CFO of Human Genome Sciences and Sepracor, Inc.