Strongbridge Starts Another Phase 3 Trial of Its Cushing’s Therapy

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by Alice Melao |

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Another Recorlev trial

Strongbridge Biopharma has begun dosing patients in another Phase 3 clinical trial of its Cushing’s syndrome therapy Recorlev (levoketoconazole).

The company will enroll roughly 35 patients in the LOGICS (NCT03277690). Those participating in another Phase 3 trial, SONICS (NCT01838551), can enter the LOGICS study as well.

LOGICS “marks an important milestone for the Recorlev Phase 3 clinical development program and brings us one step closer to our goal of providing a potential new treatment option to the Cushing’s syndrome community,” Fredric Cohen, the chief medical officer of Strongbridge Biopharma, said in a press release.

Recorlev, formerly known as COR-003, is an oral cortisol synthesis inhibitor for treating endogenous Cushing’s syndrome.

The medicine continues to be evaluated in the SONICS trial, which is testing ascending doses of Recorlev in 90 patients.

The study, at 42 sites, has three parts. Patients go through a dose-escalation phase lasting two to 16 weeks to determine the best treatment dose. Then they receive that dose in a six-months maintenance phase. Finally, patients are treated for an additional six months, with the possibility of dose adjustments.

LOGICS is recruiting both SONICS participants and those who have never received Recorlev. The key objective is to see if the therapy’s benefit continues after patients are taken off the treatment.

Patients who have never received Recorlev will try it for up to 19 weeks before entering the trial. Part of the lead-up to the trial will involve determining the best dose for them.

After this period, patients will be randomized to receive either Recorlev or a placebo for eight to 9 1/2 weeks. Then, in a restoration phase, patients in the Recorlev arm will continue treatment, while those in the placebo arm will return to Recorlev for an additional eight to 9 1/2 weeks.

LOGIC’s primary goal is to see how many patients lose the benefit they were receiving from Recorlev during the withdrawal phase. The key measure of whether its benefit is long-lasting will be cortisol levels in patients’ urine. Researchers will also evaluate the drug’s safety.

Strongbridge will recruit patients from more than 11 countries in Europe and North America for the LOGICS trial. You can find more information about it here.

The company expects to announce key results of the SONICS trial by mid-2018 and of the LOGICS trial in the first quarter of 2019.

“Recolev is a promising, next-generation cortisol synthesis inhibitor that could possibly have a more favorable efficacy, safety, and tolerability profile than the currently available treatments for hypercortisolemia,” said Dr. Maria Fleseriu, director of the Oregon Health & Science University’s NW Pituitary Center.  “I am pleased to be participating in the LOGICS study, which will hopefully advance our overall understanding of Cushing’s syndrome and ultimately improve treatment outcomes for patients,” added Fleseriu, the trial’s principal investigator.

Both the U.S. Food and Drug Administration and the European Medicines Agency have designated Recolen an orphan drug for the treatment of endogenous Cushing’s syndrome.