Inotek Pharmaceuticals Corp (NASDAQ:ITEK) kicked off a phase III trial back in 2015, investigating its lead candidate, Trabodenoson, in glaucoma patients. The trial completed enrollment back in August, and is set to read out on topline this month. The company has had a pretty flat year from a valuation perspective, ranging between the $6 and $10, but the Trabodenoson release is likely going to break one of these levels when it hits press. Here’s what we’re looking for on release.
So, as we’ve said, the drug is called Trabodenoson, and it’s targeting a specific form of glaucoma called primary open-angle glaucoma (POAG). POAG is progressive, and can be extremely serious if left untreated (which, in the majority of cases, it is, because there’s no real effective SOC available right now). It’s the most common cause of irreversible blindness worldwide. By was of a brief introduction to glaucoma as a condition, the name describes a group of conditions in which there is characteristic cupping of the optic disc.
The cupping leads to corresponding visual field defects, due to retinal ganglion cell loss. POAG is a subset of glaucoma defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease. That latter statement is important. If there’s an identifiable underlying disease, it doesn’t qualify as POAG, instead being what’s called secondary glaucoma.
The mechanism of action for Trabodenoson is pretty complicated, but can be described in a relatively simple way if we do it abstractly. The IOP that characterizes the condition is caused by fluid buildup. In our eyes, we’ve got what’s called a trabecular meshwork (TM) that, in patients with POAG, becomes increasingly resistant to fluid outflow. Normally, a nucleoside called adenosine stops the resistance from happening, but in POAG patients, there’s a lack of effective adenosine. Trabodenoson is designed to mimic the action of adenosine, and by proxy, to reduce the TM resistance. Reduced resistance translates to a reduction in IOP.
The drug has performed well in trials to date, with readouts pointing both to safety and degree of clinical benefit, but this legacy data won’t mean much if Inotek Pharmaceuticals Corp (NASDAQ:ITEK) cannot replicate it in the current phase III. So what are we looking for?
The trial has enrolled roughly 330 patients in the US, and is investigating three different doses of the drug – 3% (1000 mcg) once daily, 4.5% (1500 mcg) twice daily, and 6% (2000 mcg) once daily. There’s also an arm that received a drug called Timolol, which is an SOC treatment aimed at reducing IOP, currently widely used in the US. This arm is an internal control arm, and there’s a further arm that will receive placebo. The primary endpoint is reduction of IOP as compared to the placebo treatment arm.
So that’s what we’re looking for. Across the active doses, we want to see a higher degree of IOP reduction when compared to the placebo arm and the Timolol arm. The latter of these two isn’t quite as important as the former, but if Trabodenoson performs against placebo, we would expect it to do the same against the medicated control. Safety shouldn’t be an issue – there’s plenty of legacy data validating this one as safe – but, of course, we don’t want to see any safety issues arise as part of this expanded patient sample.
When’s the data expected to hit? Inotek Pharmaceuticals Corp (NASDAQ:ITEK) has reported on a number of occasions that it will put out data from the trial at some point during early January. The assumption, then, is that this puts the first couple of weeks of this month in the picture. As such, any day between now and (at the latest) Friday January 16 is a potential for release.
Note: This article is written by Mark Collins and was originally published at Market Exclusive.