Inotek Pharmaceuticals announced the Journal of Ocular Pharmacology and Therapeutics (JOPT) has published the results from its phase 1 dose-escalation trial in healthy adult volunteers of the company’s lead product candidate, trabodenoson, according to a company news release. These results support the ongoing clinical development of trabodenoson as a novel treatment for glaucoma, and follow publication of the phase 2 study in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), announced on April 11, 2016.
The research article, “A Randomized Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Trabodenoson in Healthy Adult Volunteers,” presents data showing that ocular doses of trabodenoson up to 3,200 ug per eye were safe and well tolerated both in the eye and systemically in healthy adult volunteers. Trabodenoson is a wholly-owned, first-in-class selective adenosine mimetic designed to lower IOP through its action at the trabecular meshwork, the site of natural IOP regulation.
“Inotek continues to build a compelling body of safety and efficacy data for trabodenoson as a potential novel approach for the treatment of glaucoma,” Rudolf Baumgartner, MD, Chief Medical Officer of Inotek, said in the news release. “Notably, the data from this multi-dose phase 1 trial showed no dose-related ocular or systemic side effects even when administered at higher doses than those being evaluated in the ongoing phase 3 trial, MATrX-1.”
“We believe the good-ocular tolerability of trabodenoson may stem, in part, from its structural similarity to naturally occurring adenosine. By activating the A1 adenosine receptor, and enhancing part of the intrinsic IOP regulating process of the trabecular meshwork rather than changing the fundamental dynamics of pressure regulation in the eye, we believe trabodenoson’s mechanism of action carries a lower risk of unintended side effects with long term chronic use in patients with glaucoma,” William McVicar, PhD, Chief Scientific Officer of Inotek, said in the news release.
About the Phase 1 Study
The phase 1 study was a randomized, double-masked, placebo-controlled dose escalation study designed to characterize the systemic and local ocular safety and tolerability of trabodenoson delivered via topical ophthalmic dosing. Overall, 70 adult healthy volunteers were enrolled in this USA-based trial. Key exclusion criteria included best-corrected visual acuity worse than 20/60 in either eye, active eye disease and other factors.