Inotek’s trabodenoson shows no clinical advantage in Phase II FDC trial for glaucoma
Inotek Pharmaceuticals has reported top-line results from the Phase II fixed-dose combination (FDC) trial of trabodenoson and latanoprost in patients suffering from glaucoma.
The 3% trabodenoson and 0.005% latanoprost combination indicated a 1.2mmHg improvement in intraocular pressure (IOP) reduction, when compared to 0.005% latanoprost alone, following once-daily morning treatment (QAM) for 28 days.
The trial is however said to have demonstrated no significant reduction in IOP at day 56.
Inotek Pharmaceuticals president and CEO David Southwell said: “While the top-line results, which we received and analysed over the past week, demonstrated a good safety and tolerability profile of the fixed-dose combinations of trabodenoson and latanoprost, the efficacy of the FDC was only marginally differentiated from that of latanoprost alone.
“Based on these results and the results previously reported for our Phase III MATrX-1 monotherapy trial, we are evaluating the future clinical potential of trabodenoson, as well as other strategic options.”
Designed to evaluate the risk profile of various fixed-dose combinations, the randomised, double-masked, dose-ranging Phase II trial assessed the combination of 3% and 6% trabodenoson with 0.005% or 0.0025% latanoprost as a topical application over eight weeks in 201 primary open-angle glaucoma patients.
While latanoprost doses were chosen depending on efficacy and safety profiles, trabodenoson doses were selected to optimise reduction of IOP, as well as the tolerability and safety profile.
The safety and tolerability events during the trial were consistent with previous trabodenoson trials, and only one subject is reported to have discontinued the study because of an adverse treatment-related event.
Image: Inotek Pharma develops therapies for eye diseases. Photo: courtesy of Alexageev via Wikipedia.