Inotek Announces Top-Line Results of Phase II Fixed-Dose Combination Trial, Explores Strategic Alternatives
Inotek Pharmaceuticals Corporation recently announced top-line results of the Phase 2 fixed-dose combination (FDC) trial of trabodenoson and latanoprost for the treatment of glaucoma. The trial was designed to assess the benefit/risk profile of the different fixed-dose combinations being evaluated. It was not powered for statistical differences among doses. After 28 Days of once-daily morning treatment (QAM), the fixed combination of trabodenoson 3% and latanoprost 0.005% showed a 1.2-mmHg improvement in intraocular pressure (IOP) reduction compared to the latanoprost 0.005% alone (p=0.061 for the mean comparison, p=0.020 for the median comparison). However, at Day 56, after 4 additional weeks of treatment and night-time dosing (QPM), no meaningful clinical advantage in IOP reduction for the fixed dose combinations was observed.
“While the top-line results, which we received and analyzed 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. When dosed in the AM and examined on Day 28, the trabodenoson 3%/latanoprost 0.005% combination showed 1.2 mmHg additivity to commercial latanoprost. However by Day 56, while the IOP lowering effect of latanoprost improved by 1.3 mmHg, the fixed dose combination of trabodenoson/latanoprost remained unchanged. Therefore, the addition of trabodenoson to latanoprost offered no clinically meaningful advantage in eye pressure reduction over latanoprost alone,” commented David P. Southwell, President and Chief Executive Officer of Inotek. “Based on these results and the results previously reported for our Phase 3 MATrX-1 monotherapy trial, we are evaluating the future clinical potential of trabodenoson, as well as other strategic options.”
Mr. Southwell continued, “We remain focused on the interests of Inotek shareholders and are committed to enhancing shareholder value. Inotek is well-capitalized with an estimated $109 million in cash and marketable securities as of the end of the second quarter of 2017.”
Inotek also announced it is exploring its strategic alternatives. It has engaged Perella Weinberg Partners as a financial advisor to assist with the strategic review process. There can be no assurance a transaction will result from this process and Inotek does not intend to disclose additional details unless and until it has entered into a specific transaction or otherwise determines that further disclosure is appropriate.
Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapies for glaucoma and other eye diseases. For more information, visit www.inotekpharma.com.
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