One of Inotek Pharma’s competitors within the Biotechnology space, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), is estimated to report earnings on May 04, 2017. AWS will be initiating a research report on Regeneron Pharma following the release of its next earnings results.
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Inotek Pharma’s Trabodenoson is a highly selective adenosine mimetic that lowers intraocular pressure (IOP) by augmenting the natural function of the trabecular meshwork, the primary outflow pathway in the eye. Latanoprost, a prostaglandin Analog, targets the secondary uveoscleral pathway and is the most commonly used drug for lowering IOP.
Phase-2 Fixed-dose Combination Study of Trabodenoson and Latanoprost
Inotek stated that the randomized, double-masked, Phase-2 dose-ranging trial will assess the overall benefit/risk profile of binocular topical application of different daily doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost for eight weeks in patients with ocular hypertension or primary open-angle glaucoma.
During the study, three treatment combinations of trabodenoson and latanoprost will be investigated as well as two separate concentrations of latanoprost alone. The treatments are: trabodenoson 6%/latanoprost 0.005%, trabodenoson 3%/latanoprost 0.005%; trabodenoson 6%/latanoprost 0.0025%; latanoprost 0.005%; and latanoprost 0.0025%. Trabodenoson doses were selected to optimize IOP lowering, while maintaining the favorable tolerability and safety profile observed to date. Latanoprost doses were selected based on efficacy and safety profiles which vary based on dose.
The trial enrolled approximately 200 patients (original Enrollment was exceeded due to a lower than anticipated screen failure rate) with an IOP greater than or equal to 25 mmHg and less than or equal to 34 mmHg, which represents the patients most likely to receive treatment for glaucoma or ocular hypertension. Following a placebo run-in period, treatment will be administered to both eyes for a total of eight weeks.
“We have completed active recruitment of glaucoma patients in our Phase-2 FDC trial,” said David P. Southwell, President and Chief Executive Officer of Inotek, “This is an important milestone as we continue to believe our FDC program has the potential to address a larger market opportunity than monotherapy and provide patients with a novel treatment option that includes two complementary eye pressure lowering mechanisms. We look forward to reporting the top-line results in July.”
Meeting with FDA
Inotek also announced that the Company has secured a meeting with the US Food and Drug Administration (FDA) in the second quarter to discuss the trabodenoson monotherapy program.
“Inotek has submitted a briefing book to the FDA detailing the results of the completed MATrX-1 trial in order to seek their guidance on its continued development,” said Rudolf Baumgartner, MD, Executive Vice President and Chief Medical Officer of Inotek, “We look forward to communicating the potential path forward for the monotherapy program once it is better defined.”
At the closing bell, on Tuesday, April 11, 2017, following the announcement, Inotek Pharma’s stock jumped 5.41%, ending the trading session at $1.95. A total volume of 530.74 thousand shares were traded at the end of the day. In the last month and previous three months, shares of the Company have advanced 9.86% and 11.43%, respectively. At Tuesday’s closing price, the stock’s net capitalization stands at $54.05 million.
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