- Eye drug developer Inotek Pharmaceuticals didn't have a strong start to the new year, announcing Tuesday its lead candidate failed in late-stage testing.
- Trabodenoson aims to treat patients with primary open-angle glaucoma or ocular hypertension. In a Phase 3 study dubbed MATrX-1 that enrolled 303 patients with either of those diseases, the drug missed its primary endpoint of reducing intraocular pressure at all time points.
- Safety results were more positive. Patients showed similar tolerance for the drug as for placebo, and just four quit the study early due to adverse side effects.
Ophthalmology drugs are hot in the industry right now, offering big returns if developers can wade through the exceedingly difficult science behind them.
That interest, however, paired with trabodenoson being Inotek's sole pipeline product made the MATrX-1 results a hard pill to swallow for investors. The company's stock traded at $1.75 per share at close-of-market Tuesday, a 71% decline from the previous close on Dec. 30.
Still, there were a couple bright spots. In addition to the strong safety profile, the drug at a 6% formulation once-daily dose did reduce intraocular pressure significantly more than placebo.
The randomized, double-masked, placebo-controlled study evaluated three doses of trabodenoson, also including a 3% once-daily dose and a 4.5% twice-daily dose. The progress of patients' intraocular pressure was recorded at days 28, 42 and 84 at four time periods: 8 a.m., 10 a.m., 12 p.m. and 4 p.m. According to Inotek's CEO David Southwell, the drug's failure "was driven primarily by the unexpectedly stronger placebo response at the 8 a.m. time point."
"Looking ahead, 2017 is an important year for the trabodenoson development program." Southwell said in a Jan. 3 statement. "We will wait for the full results from MATrX-1 to better understand the behavior of the placebo arm."
Inotek is also testing the drug as a fixed-dose combination therapy with latanoprost, another drug known to treat intracular pressure. The combo treatment is currently in Phase 2, with top-line data expected sometime in mid-2017. Inotek didn't disclose any further details about the next steps for investigating the drug as a monotherapy.