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Phase 3 clinical trial strategy developed for Inotek’s trabodenoson
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Inotek Pharmaceuticals intends to begin a phase 3 clinical trial of its leading glaucoma drug candidate, trabodenoson, in the fourth quarter of 2015, the company announced in a press release.
The phase 3 clinical trial design incorporates feedback from an end-of-phase 2 meeting between the FDA and Inotek.
In phase 2 trials, a 200-mg and a 500-mg dose of trabodenoson, a first-in-class selective adenosine mimetic, both demonstrated statistically significant IOP lowering compared with placebo at 14 days. At 28 days, the 500-mg group continued to demonstrate a statistically significant reduction in IOP, according to the release.
The phase 3 trial will be a five-arm superiority trial of three doses of trabodenoson, with a primary efficacy endpoint of IOP reduction, the release said. Timolol will be used as a comparator in one arm of the study for validation only and not for statistical analysis.
Top-line data are expected in 2016, the release said.