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Investors in Inotek Pharmaceuticals(NASDAQ: ITEK),a clinical-stage biopharma focused on diseases of the eye, are having a tough start to the new year. Shares are collapsing in early-morning trading on Tuesday, falling more than 68% as of 10:05 a.m EST after the company reported results from a phase 3 study that failed to meet its primary endpoint.
Inotek Pharmaceuticals announced top-line results of its MATrX-1 trial on Tuesday. This study was testing the company's lead compound -- trabodenoson-- as a hopeful treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
TheMATrX-1 study was a placebo-controlled trial that was designed to assess the efficacy, safety, and tolerability oftrabodenosonover a three-month period. The study's primary endpoint was areduction of intraocular pressure as compared to the placebo group when measured atfour separate time points on days 14, 28, 42, and 84. The drug was also administered in three separate formulations: 3%/1,000 mcg once daily, 4.5%/1,500 mcg twice daily, and 6%/2,000 mcg once daily.
Unfortuanlty, top-line results from the trial showed that trabodenosonfailed to achieve clinical superiority to placebo at all of its measured time points.
Inotek CEODavid Southwell stated that he was disappointed with the results but noted that the miss "was driven primarily by the unexpectedly stronger placebo response at the8AMtime point." He later went on to say that the company is waiting for additional data from the trial before they will determine next steps.
Given that this was the company's most advanced clinical program, it is no surprise to see that shares are tanking on the news.
While this clinical result is very disappointing, management did point out that the 6% dose of trabodenosondid show astatistically superior result over placebo at days 84, 42, 14, and a marginally superior result at day 28. In addition, there were no significant safety or tolerability events reported and the study's discontinuation rate was only 2.2%. Those figures could suggest that there is still some hope for this program.
Looking ahead, the company is planning to announce results from its phase 2 trial using trabodenoson in combination with latanoprost as a hopeful treatment for glaucomalater this year. If that trial shows more encouraging results, then it is possible that shares could start to bounce back from Tuesday's drubbing.
Still, there's no doubt that this report casts doubts overtrabodenoson'sefficacy. For that reason, I'd recommend that potential investors look elsewhere for opportunities.
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