Inotek Pharmaceuticals Announces the Journal of Ocular Pharmacology and Therapeutics has Published its Phase 2 Data for Trabodenoson in Patients with Glaucoma and Ocular Hypertension
Inotek Pharmaceuticals Corporation (the "Company" or "Inotek") (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced the Journal of Ocular Pharmacology and Therapeutics has recently published the results from a Phase 2 study of the Company's lead product candidate, trabodenoson, in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Data from this trial demonstrated that trabodenoson was well tolerated and had significant reductions in intraocular pressure (IOP). Trabodenoson is a first-in-class selective adenosine mimetic designed to lower IOP at the trabecular meshwork (the natural site of IOP regulation), and is currently in Phase 3 development.
"Patients with glaucoma have limited therapeutic options that provide reduction in intraocular pressure with good tolerability," commented David P. Southwell, President and Chief Executive Officer of Inotek. "The data from this Phase 2 trial demonstrate the potential of trabodenoson to provide clinically meaningful reductions in IOP with a favorable safety profile."
The research article entitled "A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 and 4 Weeks of Twice-Daily Ocular Trabodenoson in Adults with Ocular Hypertension or Primary Open-Angle Glaucoma," demonstrates that ocular doses of trabodenoson, from 50 to 500 mcg, were well tolerated and showed a dose-related reduction in IOP that was statistically significant and clinically relevant at 500 mcg in patients with POAG or OHT. No clinically meaningful ocular or systemic side effects were identified. Additionally, there were no trabodenoson-related discontinuations in the trial.
"These favorable safety and efficacy data are consistent with other clinical trials of trabodenoson in glaucoma. Importantly, these results provided guidance for the design of the ongoing pivotal Phase 3 (MATrX-1) trial, from which we anticipate topline data in the fourth quarter of 2016," said Rudolf Baumgartner, MD, Chief Medical Officer of Inotek.
About the Phase 2 Study
The Phase 2 study was a multicenter, randomized, double-masked, placebo-controlled, dose-escalation trial in patients with POAG or OHT. IOP was assessed using Goldmann applanation tonometry. The primary efﬁcacy endpoint was mean IOP measured over 12 hours versus placebo. Subjects were 18–77 years old and diagnosed with POAG or OHT with a baseline IOP ≥ 24 mmHg (on no IOP lowering therapy). Exclusion criteria included best-corrected visual acuity worse than 20/60 in either eye, advanced glaucoma and other factors.
ABSTRACT LINK: http://www.ncbi.nlm.nih.gov/pubmed/27002298
ARTICLE REFERENCE: Journal of Ocular Pharmacology and Therapeutics. March 2016, ahead of print. doi:10.1089/jop.2015.0148. Study authors; Jonathan S. Myers1, Kenneth N. Sall2, Harvey DuBiner3, Natanya Slomowitz4, William McVicar4, Cadmus C. Rich4 and Rudolf A. Baumgartner4.
1Wills Eye Hospital, Philadelphia, Pennsylvania
2Sall Research Medical Center, Artesia, California
3Eye Care Centers Management, Inc., Morrow, Georgia
4Inotek Pharmaceuticals Corporation, Lexington, Massachusetts
About Inotek Pharmaceuticals Corporation
Inotek is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. The Company's lead product candidate, trabodenoson, is a first-in-class selective adenosine mimetic currently in Phase 3 development. Trabodenoson was developed in Inotek's laboratories and is designed to restore the eye's natural pressure control mechanism. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases. For more information, please visit http://inotekpharma.com/
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Claudine Prowse, Ph.D.
Vice President, Strategy and Investor Relations Officer