Inotek Pharmaceuticals Announces Positive End-of-Phase 2 Meeting with FDA and Phase 3 Development Strategy for Trabodenoson, a Novel Treatment for Glaucoma
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--Pivotal Studies Designed to Show Superiority to Placebo--
--1st Phase 3 Study to Commence in 4Q15 with Top-line Data In 2016--
--Conference Call Scheduled for
“Our End-of-Phase 2 meeting was a critical milestone for advancing the
development of trabodenoson. We are pleased with the agency’s guidance
on the pivotal trial design which will enable a more efficient
registration path to potentially bring this novel glaucoma therapy to
market for the benefit of patients,” said
The trial design for the first pivotal study is a five-arm superiority trial that will include three doses of trabodenoson. These doses were selected to optimize lowering of intraocular pressure while maintaining the good tolerability observed in Phase 2 trials. The primary efficacy endpoint of the study is the reduction of intraocular pressure (IOP), statistically superior as compared to placebo. A comparator arm of timolol will also be included for study validation, but not for statistical comparison.
“There is a major unmet medical need for a well-tolerated and effective
therapy with a new mechanism of action for glaucoma,” said
In Phase 2 trials, trabodenoson demonstrated a dose-response for intraocular pressure lowering in ocular hypertension and primary open angle glaucoma patients. After 14 days of treatment, both the 200mg and 500mg doses of trabodenoson demonstrated a statistically significant reduction (P<0.05) in IOP relative to the matched placebo group. After 28 days of treatment, the 500mg dose continued to demonstrate a statistically significant reduction in IOP relative to placebo, in the range of other glaucoma therapies. Across all trials, the efficacy of trabodenoson has remained consistent, with no waning effect observed, and the IOP reduction was consistent across different patient sub-populations. Trabodenoson has also been well tolerated with no serious adverse events. In patients with glaucoma or ocular hypertension, the rate of conjunctival hyperemia (redness in the eye), a side-effect commonly associated with other mechanisms used to treat glaucoma, was not affected by trabodenoson treatment.
Conference Call Information
Inotek will host a conference call and webcast today,
An archive of today’s conference call will be available shortly after the conclusion of the call and accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 and referencing the Conference ID: 93395336, or by visiting Inotek’s website. The audio replay will be available for two weeks following the call and the webcast for thirty days.
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Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy and Investor Relations Officer
Karen Sharma, 781-235-3060