RECORLEVTM (levoketoconazole): Cortisol Synthesis Inhibitor for Endogenous Cushing’s Syndrome

RECORLEV (levoketoconazole), or COR-003, is an investigational cortisol synthesis inhibitor. It has received orphan designation in the US and EU for treatment of endogenous Cushing’s syndrome.

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.

3.1_sonics_trialdesign_chart_desktop

LOGICS Trial Design2

  • Double-blind, placebo-controlled, randomized withdrawal following open‑label therapy with levoketoconazole
  • Orally administered study drug
  • Approximately 40 subjects in total will be dosed to enroll 35 subjects 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.

*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*

RECORLEV (levoketoconazole) is currently being evaluated in phase 3 trials for patients with endogenous Cushing’s syndrome.

3.1_sonics_trialdesign_chart_desktop

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.

*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the SONICS trial.

References

  1. 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.
  2. 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. Accessed December 1, 2015.

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