Cushing’s syndrome 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 a treatment that Stonebridge Biopharmae is developing for endogenous Cushing’s syndrome. 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 are a wide range of Cushing’s symptoms, including obesity, high blood and sugar levels, bone problems, fatigue and many others.
How Recorlev works
Recorlev is a cortisol synthesis inhibitor, meaning it keeps the adrenal gland from producing too much cortisol. Excess cortisol is responsible for Cushing’s syndrome symptoms.
Stonebridge Biopharma says evidence indicates that Recorlev can be a safe, effective, and well-tolerated option for patients with endogenous Cushing’s syndrome.
Recorlev in clinical trials
Each 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 cortisol by the end of the six-month maintenance period.
The participants in the SONICS trial have been diagnosed with new, persistent, or recurrent Cushing’s disease and are not candidates radiation therapy or surgery. Stonebridge Biopharma expects results from the SONICS trial to be available in early 2018. SONICS is fully enrolled, so it’s no longer recruiting participants.
On March 27, 2017, Stonebridge Biopharma announced plans for an additional Phase 3 study of Recorlev, called the LOGICS trial. LOGICS will be a nine-week placebo-controlled study. Thirty-five patients will be randomized to receive either Recorlev or a placebo. Half of the 35 participants will have completed the SONICS trial.
Recorlev has yet to obtain U.S. approval as a Cushing’s treatment, but it does have orphan drug status in both the United States and Europe. Orphan drugs are medications that have shown potential as treatments for rare medical conditions. Orphan designation makes it easier for drug developers to get through the approval process.
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