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Inotek (ITEK) Down on Poor Phase III Glaucoma Drug Data
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Shares of Inotek Pharmaceuticals Corporation plunged 71.3% after the company announced that a phase III trial on lead candidate trabodenoson failed to meet the primary endpoint.
We note that Inotek has underperformed the Zacks classified Medical Biomed/Genetics industry in the last 12 months. In fact, the stock has lost 45.1% during this period, compared with a decline of 24.6% for the industry.
The candidate is being evaluated for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The randomized, double-masked, placebo-controlled trial assessed the efficacy, safety and tolerability of trabodenoson over three months of treatment in 303 subjects diagnosed with POAG or OHT.
The trial, MATrX-1, did not achieve the primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. The primary endpoint of the MATrX-1 trial was IOP reduction compared with placebo on days 24, 42, and 84, and at 4 time points during each of these days: 8 a.m. 10 a.m. 12 p.m. and 4 p.m. The placebo response was 2–3 mmHg greater than that observed in phase II. The unfavorable results were attributed to stronger placebo response at the 8 a.m. time point.
Nevertheless, the trial achieved other clinically meaningful secondary endpoints – the 6% dose was significant compared with placebo in the daily IOP change from diurnal baseline on all days tested. Also, there was no significant safety or tolerability event reported. The safety profile of trabodenoson was comparable to placebo.
The company expects to report additional data from the trial later in the quarter. In Jul 2016, the company initiated a phase II dose-ranging trial on a fixed-dose combination of trabodenoson and Pfizer’s (PFE - Free Report) Xalatan. The trial is fully enrolled and the company expects to report data from the trial in mid 2017.
The failure of the trial was disappointing as trabodenoson is the company’s lead candidate.
Competition is intensifying in the glaucoma market with companies like Aerie Pharmaceuticals, Inc. developing a Rho kinase/norepinephrine transport inhibitor. Aerie's two lead product candidates – Rhopressa and Roclatan – are once-daily lowering IOP-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or OHT.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 23.5% in the last 12 months.
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Inotek (ITEK) Down on Poor Phase III Glaucoma Drug Data
Shares of Inotek Pharmaceuticals Corporation plunged 71.3% after the company announced that a phase III trial on lead candidate trabodenoson failed to meet the primary endpoint.
We note that Inotek has underperformed the Zacks classified Medical Biomed/Genetics industry in the last 12 months. In fact, the stock has lost 45.1% during this period, compared with a decline of 24.6% for the industry.
The candidate is being evaluated for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The randomized, double-masked, placebo-controlled trial assessed the efficacy, safety and tolerability of trabodenoson over three months of treatment in 303 subjects diagnosed with POAG or OHT.
The trial, MATrX-1, did not achieve the primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. The primary endpoint of the MATrX-1 trial was IOP reduction compared with placebo on days 24, 42, and 84, and at 4 time points during each of these days: 8 a.m. 10 a.m. 12 p.m. and 4 p.m. The placebo response was 2–3 mmHg greater than that observed in phase II. The unfavorable results were attributed to stronger placebo response at the 8 a.m. time point.
Nevertheless, the trial achieved other clinically meaningful secondary endpoints – the 6% dose was significant compared with placebo in the daily IOP change from diurnal baseline on all days tested. Also, there was no significant safety or tolerability event reported. The safety profile of trabodenoson was comparable to placebo.
The company expects to report additional data from the trial later in the quarter. In Jul 2016, the company initiated a phase II dose-ranging trial on a fixed-dose combination of trabodenoson and Pfizer’s (PFE - Free Report) Xalatan. The trial is fully enrolled and the company expects to report data from the trial in mid 2017.
The failure of the trial was disappointing as trabodenoson is the company’s lead candidate.
Competition is intensifying in the glaucoma market with companies like Aerie Pharmaceuticals, Inc. developing a Rho kinase/norepinephrine transport inhibitor. Aerie's two lead product candidates – Rhopressa and Roclatan – are once-daily lowering IOP-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or OHT.
Inotek currently carries a Zacks rank #3 (Hold).
INOTEK PHARMACT Price and Consensus
INOTEK PHARMACT Price and Consensus | INOTEK PHARMACT Quote
Key Picks in the Sector
Cambrex Corporation is a better-ranked stock in the same space, with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 23.5% in the last 12 months.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>