Strongbridge Biopharma has dosed the first four patients in its LOGICS trial, a Phase III study examining the efficacy and safety of Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.
The placebo-controlled trial will randomise approximately 35 patients with Cushing’s syndrome in more than 11 countries across North America and Europe.
Nearly half of the randomised patients will have previously completed SONICS, the company’s first Phase III trial evaluating the efficacy and safety of Recorlev.
The trial’s primary objective is comparing the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the urinary free cortisol (UFC) therapeutic response previously established during open-label levoketoconazole therapy.
After completing a screening period of up to 13 weeks, the trial will be carried out in three treatment phases. These include an open-label dose titration and maintenance phase of 14 to 19 weeks for subjects naïve to levoketoconazole or otherwise not receiving a stable therapeutic dose of levoketoconazole over the 12 weeks before enrolment.
The second phase includes a randomised-withdrawal stage of eight to 9.5 weeks during which subjects receive blinded treatment with active drug or placebo.
LOGICS’ third phase will feature a restoration period of eight to 9.5 weeks, where all subjects will receive their therapeutic dose of levoketoconazole and placebo. These will be blinded to prevent disclosure of the prior randomised therapy.
The total length of the LOGICS trial, including the screening period, is estimated to range from around 16 to 51 weeks.
LOGICS study principal investigator Maria Fleseriu said: “Cushing’s syndrome is a severe endocrine disorder that can have devastating long-term consequences when left untreated.
“Although surgery is typically the initial treatment choice for both pituitary and adrenal Cushing’s and remission rates are generally good, the risk of recurrence, especially in Cushing’s disease, remains high and can be seen up to decades after an initial diagnosis, underscoring the need for safe and effective, long-term therapeutic options.”
Strongbridge expects to provide top-line results from SONICS within this year and LOGICS in the first quarter of next year.