Amgen announces ‘positive’ results from Phase 3 trial of tepezza

Amgen (AMGN) announced positive topline results from a Phase 3 trial of tepezza administered by subcutaneous injection via an on-body injector in participants with moderate-to-severe active Thyroid Eye Disease. Tepezza OBI provides comparable efficacy to, and builds upon the success of, intravenous tepezza, the first and only medicine approved for the treatment of TED, which has now treated more than 25,000 patients worldwide. The Phase 3 tepezza OBI trial met its primary endpoint in moderate-to-severe active TED, showing a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period. Importantly, the mean proptosis reduction, a key secondary endpoint, was -3.17 mm at week 24. The trial also showed statistically significant and clinically meaningful improvements across the following additional secondary endpoints: overall responder rate; percentage of patients achieving a Clinical Activity Score of 0 or 1; change in diplopia as ordinal response categories; diplopia response rate; complete diplopia responder rate; and mean change from baseline in week 24 in the Graves’ Ophthalmopathy Quality of Life appearance subscale. Although not statistically significant, there was a numerical trend favoring tepezza OBI in the mean change in baseline at week 24 in the GO-QoL visual functioning subscale. Full results from the study will be presented at an upcoming medical congress. The overall safety results were generally consistent with the known safety profile of tepezza IV. Mild-to-moderate injection site reactions were observed with subcutaneous administration in some patients, which did not result in treatment interruption or discontinuation. The most common adverse events were muscle spasms, tinnitus, weight decrease, ear discomfort, nausea and diarrhea.