Cushing’s disease is a condition that involves the body getting too much of the hormone cortisol. The excess can come from the body overproducing it, or it can result from medications that increase cortisol production.

Recorlev (levoketoconazole, COR-003) is an investigational treatment that Stonebridge Biopharma is developing for endogenous Cushing’s disease. Endogenous means that symptoms occur because the body is producing too much cortisol. In contrast, exogenous Cushing’s occurs when people take too much cortisol-containing medication.

Too much cortisol throws off the body’s other systems. There is a wide range of Cushing’s symptoms, including obesity, high blood sugar levels, bone problems, and fatigue.

How Recorlev works

Recorlev is a cortisol synthesis inhibitor, meaning that it keeps the adrenal gland from producing too much cortisol.

According to Stonebridge Biopharma, Recorlev is a safe, effective, and well-tolerated option for patients with endogenous Cushing’s syndrome.

Recorlev in clinical trials

A Phase 3 clinical trial (NCT01838551) of Recorlev is underway, but no longer recruiting participants. The international open-label trial, called SONICS, involves 90 participants and is expected to be completed in October 2018.

Each participant is receiving oral doses of Recorlev for up to 21 weeks.  The dose is increased until the levels of cortisol in the urine — known as urinary free cortisol, or UFC — fall into a normal range.

Once a therapeutic dose is established, participants continue to take that dose for six months. The goal is to identify a range of safe and effective doses that can reduce urinary free cortisol by the end of the six-month maintenance period.

Participants in the SONICS trial have been diagnosed with new, persistent, or recurrent Cushing’s disease and are not candidates for radiation therapy or surgery.

A second global Phase 3 clinical trial (NCT03277690) named LOGICS, began in early April 2018. This trial is recruiting participants who are 18 or older who have either completed the SONICS study or who have been diagnosed with endogenous Cushing’s disease that is not due to adrenal or pituitary cancer.

This is a double-blind trial designed to assess the effectiveness, safety, and tolerability of Recorlev, as well as how the body absorbs and processes it. After a period of taking Recorlev, either in the SONICS study or in this study, some participants will be switched to a placebo and some will remain on the medication. Researchers will assess how frequently Recorlev stops working in patients who have had a period of withdrawal versus patients who have remained on the medication. Response to treatment will be assessed by measuring UFC. The study is expected to last up to 51 weeks.

Additional information

Recorlev has yet to obtain U.S. approval as a Cushing’s treatment, but it does have orphan drug status in both the U.S. and Europe. Orphan drugs are medications that have shown potential as treatments for rare medical conditions. The orphan designation makes it easier for drug developers to get through the approval process.

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