Inotek Completes Patient Recruitment in Phase 2 Trial of a Fixed-dose Combination (FDC) of Trabodenoson and Latanoprost
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- Scheduled to Meet with
“We have completed active recruitment of glaucoma patients in our Phase
2 FDC trial,” said
Inotek also announced today that the Company has secured a meeting with
About the Phase 2 Fixed-dose Combination Study of Trabodenoson and
The randomized, double-masked, Phase 2 dose-ranging trial will assess the overall benefit/risk profile of binocular topical application of different daily doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) for eight weeks in patients with ocular hypertension or primary open-angle glaucoma.
Three treatment combinations of trabodenoson and latanoprost will be investigated as well as two separate concentrations of latanoprost alone. The treatments are: trabodenoson 6%/latanoprost 0.005%, trabodenoson 3%/latanoprost 0.005%; trabodenoson 6%/latanoprost 0.0025%; latanoprost 0.005%; and latanoprost 0.0025%. Trabodenoson doses were selected to optimize IOP lowering, while maintaining the favorable tolerability and safety profile observed to date. Latanoprost doses were selected based on efficacy and safety profiles which vary based on dose.
The trial enrolled approximately 200 patients (original enrollment was exceeded due to a lower than anticipated screen failure rate) with an IOP greater than or equal to 25 mmHg and less than or equal to 34 mmHg; which represents the patients most likely to receive treatment for glaucoma or ocular hypertension. Following a placebo run-in period, treatment will be administered to both eyes for a total of eight weeks.
For more information, please visit www.clinicaltrials.gov/ct2/show/NCT02829996.
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Claudine Prowse, PhD, 781-552-4305
Vice President, Corporate Development and IRO