Strongbridge Biopharma announces findings from Phase 3 SONICS study

Strongbridge Biopharma announced the top-line findings from the extended evaluation phase of the pivotal Phase 3 SONICS study of Recorlev for the potential treatment of endogenous Cushing’s syndrome. The purpose of the six-month extended evaluation phase was to evaluate the long-term safety, tolerability and benefit-risk during chronic use of Recorlev. Overall, 60 out of 61 study participants who completed the maintenance phase elected to participate in the extended evaluation phase. Of the 60 patients that entered the extended evaluation phase, 46 patients completed it Data were collected twice, at three-month intervals, which is common practice for the long-term follow-up of chronic medical therapy for endogenous Cushing’s syndrome. Four patients discontinued due to adverse events. No patients experienced an increase in either alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal and there were no reported adverse events of special interest related to liver injury or dysfunction. The most commonly reported treatment-emergent adverse events in the extended evaluation phase were arthralgia, QTc prolongation, headache, hypokalemia and nasopharyngitis. Nausea and headache were reported at lower rates as compared to the previously reported aggregate rates of 32% and 28% from the dose titration and maintenance phases. At the end of the extended evaluation phase, normalization of mUFC was observed in 41% of patients, and normalization of, or at least 50% improvement in, mUFC was observed in 68% of patients. Clinically meaningful improvements in key cardiovascular risk markers were observed throughout the extended evaluation phase. Weight loss and reduction in body mass index continued throughout the extended evaluation phase.

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