Enrollment Completed for Phase 3 Trial Testing Recorlev for Endogenous Cushing’s Syndrome

Strongbridge Biopharma has finished enrolling patients in its Phase 3 LOGICS clinical trial assessing the safety and effectiveness of Recorlev (levoketoconazole) to treat endogenous Cushing’s syndrome, the company announced.

“The completion of enrollment of the Phase 3 LOGICS trial for [Recorlev] represents a significant milestone for Strongbridge and our rare endocrine [hormone-related] franchise,” Fredric Cohen, MD, chief medical officer of Strongbridge, said in a press release.

Top-line results are expected by the end of this year and will support a new drug application submission to the U.S. Food and Drug Administration (FDA) within six months after their release.

Recorlev, also called COR-003, is an investigational oral inhibitor of cortisol production in development for patients with endogenous Cushing’s syndrome, a medical condition in which cortisol rises to unhealthy levels due to excess hormone production by the body (as opposed to excess external cortisol from corticosteroids).

LOGICS (NCT03277690) is an ongoing Phase 3 trial designed to evaluate the safety, effectiveness, and tolerability of Recorlev in patients with endogenous Cushing’s syndrome. It will also assess the therapy’s pharmocokinetics, essentially how the body absorbs, distributes, metabolizes, and eliminates a medicine.

The study enrolled patients who had never been treated with Recorlev as well as those who had received the medication in a previous Phase 3 trial called SONICS (NCT01838551).

Participants first underwent an open-label dose titration and maintenance phase to determine the best dose of Recorlev. The company has now enrolled 44 participants in the study’s withdrawal phase, in which patients will be randomized to receive either Recorlev, up to a dose of 1,200 mg, or a placebo for a maximum of 9.5 weeks.

SONICS’ main goal is to assess how frequently Recorlev stops working in patients who have had a period of withdrawal versus patients who have remained on the medication.

The withdrawal phase will then be followed by a restoration phase, also lasting 9.5 weeks, in which both groups will receive Recorlev and placebo at the same time. This way, patients treated with Recorlev will continue to receive the medication while those randomized to a placebo during the withdrawal phase will crossover to Recorlev.

The previous SONICS study achieved its primary outcome, with 31% of patients treated with a 600 mg dose of Recorlev twice a day after a six-month maintenance phase achieving normalization of their urine cortisol levels. There was no need for dose increments.

Another 5% of patients achieved this outcome but required dose increments during the maintenance phase.

Key secondary goals were also achieved, with clinically meaningful improvements from the start of the trial in several biomarkers of heart disease, including fasting glucose and LDL-cholesterol.

“If approved, we believe that [Recorlev] could become a preferred medical therapy for the treatment of Cushing’s syndrome, a rare and potentially lethal endocrine disease,” Cohen said. “On behalf of the Company, we would like to thank the many patients who participated in our Phase 3 clinical program, as well as our study sites and investigators who were instrumental in our ability to reach this goal.”