Inotek Looks To Sell Itself After Eye Drug Failure; No Value Left

Summary

  • Company failed a phase 2 trial in patients with glaucoma which makes it a great short opportunity
  • Prior monotherapy failure was not a good indication for the combination trial
  • Company looking to sell itself if after recent failure
  • Financials show an accumulated deficit of $249.5 million

Inotek Pharmaceuticals (ITEK) announced on Friday that it had failed a phase 2 trial with its drug trabodenoson. This was a huge blow for the company and now it has decided that it would be best to explore strategic options. Although, that is easier said than done. With these trial failures on hand it will prove to be quite difficult to obtain a buyer that is willing to acquire the company's assets.

Phase 2 Trail Failure

The phase 2 trial was a fixed dose combination -- FDC -- trial. It was a randomized, double-masked trial, to observe the benefit of treating the eyes with a combination treatment of trabodenoson and latanoprost for the treatment of glaucoma. The trial enrolled 201 glaucoma patients that had intraocular pressure -- IOP -- greater than and equal to 25 mmHg and less than or equal to 34 mmHg. Patients were first given a period of receiving placebo only, then were given the combination treatment to both eyes over an 8-week period. The primary endpoint of the trial measured IOP reduction from diurnal baseline for a two month treatment period. One thing to note was that the trial was divided into two four week periods. One four week period was for AM dosing, and the other for PM dosing. The trial over the entire period failed, but Inotek noted that the first 28 days was positive. Still, the primary endpoint failed at the end and that's all that matters. The first 28 days of AM dosing saw a statistical significance of the combo treatment compared to latanoprost alone. However, at day 56 with PM dosing there was no statistical significance observed. The culprit could have been the fact that latanoprost improved by 1.3 mmHg from day 28 to day 56.

Previous Failure

The phase 2

This article was written by

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