Inotek Pharmaceuticals, 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 CEO 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.