Inotek Pharmaceuticals announced that the United States Patent and Trademark Office issued a composition of matter patent for the combination of the company’s lead product candidate, trabodenoson, with a prostaglandin analog for the treatment of IOP in patients with glaucoma, according to a company news release.
US Patent number 9,370,530 (’530 patent) further strengthens the company’s patent estate for trabodenoson and adds composition of matter intellectual property protection for the combination or kit treatment option until 2031. Trabodenoson, the company’s lead clinical product candidate, is a first-in-class, selective adenosine mimetic targeting the A1 receptor and has been observed in phase 2 clinical trials to reduce IOP, an important risk factor for glaucoma. Prostaglandin analogs are currently the most commonly used drug class for this disease.
Earlier this month, Inotek announced the initiation of their phase 2 dose-ranging trial of a fixed-dose combination (FDC) of trabodenoson and latanoprost, the most commonly used prostaglandin analog prescribed for glaucoma.
There are currently no FDC products for glaucoma treatment that include a prostaglandin analog that are approved in the United States, even though about half of glaucoma patients that start treatment with a prostaglandin require a second, adjunctive therapy to increase IOP lowering. Inotek believes an FDC of trabodenoson with latanoprost has the potential to produce efficacy greater than either drug alone in a convenient one-drop, once daily treatment option for patients with glaucoma.
“The issuance of the combination patent covering the use of trabodenoson with a prostaglandin analog is an important addition to Inotek’s growing intellectual property portfolio. This protects use of the combination of trabodenoson with any prostaglandin analog in a single, convenient daily eye drop,” David P. Southwell, President and Chief Executive Officer of Inotek, said in the news release. “We look forward to reporting data from our recently initiated phase 2 FDC trial of trabodenoson and the most commonly used prostaglandin, latanoprost, in the second half of 2017.”
The ’530 patent broadly covers the use of trabodenoson and a prostaglandin analog as a combination, kit or method of use for reducing IOP. Inotek’s patent estate also includes composition of matter patents covering the trabodenoson compound through 2026 in the United States and through 2025 abroad, the crystalline formulation of trabodenoson used in eye drops through 2033 in the United States and patents relating to the use of trabodenoson for reducing IOP, which expire in 2031 in the United States, and, if issued abroad, will expire in 2030.