RECORLEV® (levoketoconazole): Cortisol Synthesis Inhibitor for Endogenous Cushing’s Syndrome
RECORLEV (levoketoconazole), or COR-003, is an investigational cortisol synthesis inhibitor. It has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
Pituitary World News (PWN), a not-for-profit news and patient advocacy organization that seeks to raise awareness of pituitary disease and related illnesses, conducted an in-depth interview with Maria Fleseriu, M.D., FACE, professor of Medicine and Neurological Surgery and director of the Oregon Health Sciences University Pituitary Center and principal investigator of the SONICS and LOGICS studies.
The discussion addresses a range of Cushing’s syndrome topics, including the latest advances in medical treatments, new therapies on the horizon, key results from both the LOGICS and SONICS Phase 3 studies of RECORLEV, and the associated challenges and unmet needs in the diagnosis and treatment of the disease.
RECORLEV (levoketoconazole): A Pure Enantiomer of Ketoconazole
RECORLEV (levoketoconazole) is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor used to treat endogenous Cushing’s syndrome. Ketoconazole is recommended for use in treating Cushing's syndrome,1 but is not approved for that use in the US. We believe that RECORLEV (levoketoconazole) may have favorable efficacy, safety, and tolerability for patients with endogenous Cushing’s syndrome.
PHASE 3 CUSHING'S SYNDROME TRIALS
LOGICS: A Global Phase 3 Trial in Endogenous Cushing’s Syndrome*
Levoketoconazole is currently being evaluated in phase 3 trials for patients with endogenous Cushing’s syndrome.
LOGICS Trial Design
- Double-blind, placebo-controlled, randomized withdrawal following open‑label therapy with levoketoconazole
- Orally administered study drug
- Up to 54 subjects will be enrolled in the randomized-withdrawal phase of the study
- Approximately 40 sites globally
- Dose titration and maintenance phase to therapeutic dose for levoketoconazole naive subjects (14 to 19 weeks)
- Double-blind randomized withdrawal phase (8 to 9 1/2 weeks)
- Double-blind restoration phase (8 to 9 1/2 weeks)
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the LOGICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the LOGICS trial.
SONICS: A Global Phase 3 Trial in Endogenous Cushing’s Syndrome*
The SONICS study, now completed, assessed normalization of mUFC at the end of 6 months of maintenance therapy.
SONICS Trial Design2
- Single-arm, open-label study
- Orally administered study drug
- Enrollment goal: 90 patients
- Approximately 90 sites globally
- Titrate to therapeutic dose (weeks 2–21)
- 6-month maintenance phase on therapeutic dose
- 6-month extended evaluation
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the SONICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the SONICS trial.
OPTICS: A Long-term Global Phase 3 Trial in Endogenous Cushing's Syndrome*
The OPTICS study, currently recruiting, is an open-label extension study in those who previously completed either the LOGICS trial, the SONICS trial, or both.
OPTICS Trial Design3
- Single-arm, open-label extension study
- Orally administered study drug
- Approximately 30 sites globally
- Maintenance of therapeutic dose for up to 3 years
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the OPTICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the OPTICS trial.
References
- Nieman LK, Biller BMK, Findling MHM, et al. Treatment of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100:2807-2831.
- Salvatori R, DelConte A, Geer EB, et al. An open-label study to assess the safety and efficacy of levoketoconazole (COR-003) in the treatment of endogenous Cushing’s syndrome. Presented at: The Endocrine Society’s 97th Annual Meeting & Expo; March 6, 2015; San Diego, CA. https://endo.confex.com/endo/2015endo/webprogram/Paper20580.html.
- U.S. National Library of Medicine. Open-label treatment in Cushing’s syndrome (OPTICS). Available at: https://clinicaltrials.gov/ct2/show/NCT03621280.