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
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Trabodenoson Well Tolerated with Meaningful Reductions in Intraocular Pressure
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
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
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
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