Strongbridge Close to Completing Patient Enrollment for Phase 3 Trial Testing Recorlev for Endogenous Cushing’s Syndrome

More than 70% of patients have been enrolled in Strongbridge Biopharma’s Phase 3 LOGICS clinical trial assessing the safety and effectiveness of Recorlev (levoketoconazole) for treating endogenous Cushing’s syndrome, the company announced.

Strongbridge anticipates announcing top-line results from the study before the end of this year and plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) requesting the approval of Recorlev within six months after reporting the findings.

“As we enter this next phase of growth, our priorities remain focused on completing the Phase 3 LOGICS trial, [and] submitting a quality new drug application for Recorlev (levoketoconazole),” John H. Johnson, executive chairman of Strongbridge Biopharma, said in a press release.

Recorlev is an investigational oral cortisol synthesis inhibitor being developed to treat 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).

The inhibitor contains the pure active component of ketoconazole, a compound that blocks the production of cortisol and has been used as an off-label treatment for Cushing’s for a long time.

The therapy previously received orphan drug status from the FDA and European Medicines Agency (EMA) as a treatment for endogenous Cushing’s syndrome.

LOGICS (NCT03277690) is a multi-center, randomized, placebo-controlled trial designed to assess the safety, effectiveness, tolerability, and pharmacokinetic properties of Recorlev in patients with endogenous Cushing’s syndrome. Pharmacokinetics studies how a drug is absorbed, distributed, metabolized, and eliminated from the body.

The trial is recruiting patients who have never been treated with Recorlev, as well as those who participated in the SONICS Phase 3 trial (NCT01838551), the first study in Recorlev’s clinical trial program in which all patients received the active ingredient.

Patients who have never been treated with Recorlev will first enroll in an open-label dose titration and maintenance phase lasting 14 to 19 weeks to determine the best dose of Recorlev for them. Strongbridge stated that about a third of the patients who are still waiting to be enrolled in the study are currently in this phase.

Following this initial phase, participants will move into the trial itself, where they will be assigned randomly to receive either Recorlev or a placebo for eight to 9.5 weeks (withdrawal phase).

This will be followed by a restoration phase, also lasting eight to 9.5 weeks, in which both groups will receive Recorlev and placebo at the same time. This means that patients receiving Recorlev during the withdrawal phase will continue treatment, while those who were on a placebo during the withdrawal phase will crossover to Recorlev.

LOGICS’ main goal is to assess the effects of Recorlev withdrawal on the levels of cortisol in the patients’ urine, compared to patients who remained on Recorlev.

Previous results have shown that SONICS met its primary outcome, with 31% of the patients achieving normalization of their urine cortisol levels after a six-month maintenance phase in which they received Recorlev twice-a-day at a dose of 600 mg, without requiring dose increments.

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

SONICS also met key secondary goals, with several biomarkers of heart disease, including fasting glucose and LDL-cholesterol, showing clinically meaningful improvements from baseline until the end of the study’s maintenance phase.