Inotek announces positive results for phase 1/2 study of glaucoma drug candidate

LEXINGTON, Mass. — Inotek Pharmaceuticals' lead product candidate, a selective adenosine-1 agonist for treating glaucoma, was well-tolerated and resulted in a statistically significant reduction in IOP in a phase 1/2 clinical trial, the company announced.

The randomized, double-blind, placebo-controlled, single ascending-dose study evaluated the safety, tolerability and efficacy of the drug, called INO-8875, when administered topically to 84 patients with primary open-angle glaucoma or ocular hypertension, according to a press release from the company.

The investigators found that INO-8875 was well-tolerated up to the highest dose tested with no evidence of serious adverse events and no observed dose-limiting toxicities. In addition, the drug increased the outflow of ocular fluid through the trabecular meshwork and demonstrated linear, dose-proportional pharmacokinetics, with minimal systemic absorption, the release said.

"These data suggest that INO-8875 has the potential to become a meaningful therapeutic for patients with glaucoma," Rudolf Baumgartner, MD, chief medical officer of Inotek, said in the release. "By leveraging the effects of INO-8875, physicians may be able to add a new mechanism of action for lowering IOP to their treatment armamentarium to reach individualized target IOP levels and reduce vision loss associated with glaucoma."

Inotek plans to release complete study results at a future medical meeting and to initiate a multiple dose phase 2 study of INO-8875 next year.