Last Patient Completes Withdrawal Phase of Recorlev Trial for Cushing’s

The last patient has completed the last study visit in the withdrawal phase of the Phase 3 LOGICS clinical trial that is investigating the safety and effectiveness of Recorlev (levoketoconazole) in patients with endogenous Cushing’s syndrome.

The announcement by Strongbridge Biopharma, the therapy’s developer, says that LOGICS (NCT03277690) has completed patient enrollment, recruiting a total of 44 participants. The company remains on track to announce top-line data from the trial before the end of the year. The information will support a new drug application (NDA) Strongbridge plans to submit to the U.S. Food and Drug Administration (FDA) within six months of its release to request the approval of Recorlev for this indication.

“We are very pleased to have accomplished this important clinical milestone for Recorlev (levoketoconazole) and look forward to reporting topline data in the third quarter of this year,” Fredric Cohen, MD, chief medical officer of Strongbridge Biopharma, said in a press release.

“We are very grateful to the investigators, the patients, and their families for working together during the unprecedented global COVID-19 pandemic to make this study possible — moving us one step closer to the possibility of bringing this next-generation treatment to people with endogenous Cushing’s syndrome,” Cohen said.

Recorlev, also known as COR-003, is an investigational oral treatment for endogenous Cushing’s syndrome that works by blocking the production of cortisol, the hormone that is overly produced in patients with the disorder.

LOGICS is a two-part Phase 3 trial that is assessing the safety, tolerability, effectiveness, and pharmacological properties of Recorlev in patients with endogenous Cushing’s syndrome.

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

LOGICS comprises an initial withdrawal phase, in which patients will be assigned randomly to receive either Recorlev (up to a dose of 1,200 mg), or a placebo, for a maximum of 9.5 weeks. This will be followed by a restoration phase, also lasting up to 9.5 weeks, in which all patients will receive Recorlev in combination with a placebo. With this design, patients initially assigned to Recorlev will continue treatment in the study’s second phase, while those originally assigned to a placebo will switch to Recorlev.

According to the company, a total of 43 patients out of the 44 enrolled, have completed the study’s initial withdrawal phase.

Top-line data from LOGICS is expected to complement Recorlev’s prior safety and effectiveness findings provided by SONICS, which showed the medication safely normalized the levels of cortisol found in the urine of approximately one third of the study participants within a six-month period.

Recorlev previously received the designation of orphan drug for the treatment of endogenous Cushing’s syndrome by the FDA and the European Medicines Agency (EMA).