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Inotek starts off 2017 with a PhIII failure for lead drug, shares crater

Rudolf Baumgartner, Inotek

The New Year in biotech got started this morning in just the same style it ended 2016; with a small biotech reporting a late-stage failure for a lead drug and watching its share price crater.

Today it was Inotek’s $ITEK turn to find the best spin possible after trabodenoson flunked its first Phase III for glaucoma or ocular hypertension. The drug failed the primary endpoint, reducing intraocular pressure at 12 time points over 84 days of treatment. And its stock immediately plunged more than 60%.

Researchers pinned the blame on an unexpectedly high placebo response, an unusual issue for a study on ocular pressure.

Looking on the bright side of a bad situation, investigators for the Lexington, MA-based biotech added that the study did hit some of the secondaries, including a better response with the 6% dose compared to the placebo group.

Researchers checked patients’ IOP at four time points – 8 AM to 4 pm – after 28, 42 and 84 days of therapy. But the study was scuttled by the 8 AM’s inability to separate from placebo.

“The results of the MATrX-1 trial demonstrate that trabodenoson, operating through a novel mechanism of action, actively lowers IOP with a tolerability profile that, remarkably, was similar to that observed in the placebo arm,” commented Rudolf Baumgartner, MD, Executive Vice President and Chief Medical Officer of Inotek.


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RAPS Regulatory Convergence 2017