Health and Healthcare

Is This the Implosion of Inotek?

Chris Lange

Published: January 3, 2017 10:20 am

Last Updated: January 12, 2020 4:13 pm

Inotek Pharmaceuticals Corp. (NASDAQ: ITEK) saw its shares get more than halved early on Tuesday after the company provided an update on its late-stage glaucoma trial. Unfortunately, the Phase 3 top-line results of MATrX-1 in the trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) did not live up to expectations.

As we have said before, the results of clinical trials as well as U.S. Food and Drug Administration (FDA) decisions have the potential to make or break companies in the biotech and pharmaceutical industries. 24/7 Wall St. has put together an FDA calendar for some key decisions and catalysts coming out for these industries in January and February.

The Inotek trial did not achieve its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. This was, in part, due to a placebo response that was much greater than that observed in Phase 2.

For some brief background: Trabodenoson lowers IOP by augmenting the eye’s natural function of the trabecular meshwork, the primary outflow pathway for aqueous humor and a site of pathology in glaucoma.

David P. Southwell, president and CEO of Inotek, commented:

We are disappointed that the primary endpoint of superiority at all 12 time points was not achieved. This result was driven primarily by the unexpectedly stronger placebo response at the 8AM time point. However, MATrX-1 did achieve several clinically meaningful secondary endpoints- the 6% dose was significant versus placebo in the daily IOP change from diurnal baseline at all days tested. Additionally, an analysis of responders (subjects with IOP reduction of 5mmHg or greater from baseline) indicated a statistically higher proportion of responders in the 6% trabodenoson group than the placebo group at all visits. The safety, tolerability and low discontinuation rate in MATrX-1 continues to suggest that trabodenoson is an active molecule with a unique safety profile. Later this quarter, we expect to receive additional data beyond the top-line results reported today. Once we have the additional data, we will determine next steps in the trabodenoson monotherapy program.

Shares of Inotek traded Monday morning at $1.95, down about 68%, with a consensus analyst price target of $23.20 and a previous post-IPO trading range of $5.81 to $10.90.