Enrollment Complete for Phase 3 Recorlev Trial for Endogenous Cushing’s Syndrome

The multicenter, international Phase 3 SONICS study testing the safety and effectiveness of Strongbridge Biopharma’s therapy candidate Recorlev (levoketoconazole) for endogenous Cushing’s syndrome has reached its goal of enlisting 90 participants, which completes the enrollment phase.

Due to strong interest in the study, a small number of patients still under evaluation may be able to enter the study if they meet the qualifications.

“We currently still have patients in screening for SONICS due to the high level of interest and demand in the study. Although we have reached target enrollment, we are pleased to extend the study for a brief period to accommodate those in screening who qualify. This will enable us to report top-line results in the second quarter of 2018,” Fredric Cohen, Strongbridge Biopharma’s chief medical officer, said in a press release.

Recorlev, formerly known as COR-003, is an investigational oral cortisol synthesis inhibitor. It has been granted orphan drug designation by the U.S. Food and Drug Administration and by the European Medicines Agency (EMA) for the treatment of endogenous Cushing’s syndrome.

The SONICS study (NCT01838551) will evaluate Recorlev’s effectiveness in reducing cortisol levels, measured in urine samples, as well as to determine treatment safety and tolerability. The study is being conducted in 87 centers in the United States, Europe, Canada, and the Middle East.

SONICS will be conducted in three parts: a dose-escalation phase lasting from two to 16 weeks designed to determine the best treatment dose; a maintenance phase where patients receive the therapeutic dose for six months; and a final extended evaluation phase, where patients receive treatment for an additional six months after the maintenance phase.

“The need for a safe and effective, next-generation cortisol synthesis inhibitor, such as Recorlev, in the treatment of Cushing’s syndrome is substantial. Through achieving target enrollment in the SONICS study, we are one step closer to better understanding the clinical value of Recorlev and potentially bringing a new therapeutic treatment option to this community,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma.

The company plans to initiate another Phase 3 trial, called LOGICS, in the third quarter of 2017. This additional placebo-controlled, randomized-withdrawal study will include 35 patients with Cushing’s syndrome, of which approximately half completed the SONICS study.

“Because we strongly believe in the potential of Recorlev to become a best-in-class therapy, and as previously announced, we have strengthened our Phase 3 development plan to include LOGICS, a nine-week, placebo-controlled study, which will complement the long-term SONICS study. We anticipate availability of top-line data from the LOGICS study in the third quarter of 2018,” Pauls said.