Strongbridge Biopharma slips despite unveiling promising Phase 3 trial data for Cushing's syndrome drug

Shares of Strongbridge Biopharma (NASDAQ:SBBP) slipped Monday despite the biopharma company unveiling promising data from a key Phase 3 SONICS study which evaluated its drug Recorlev (levoketocanazole) for the treatment of endogenous Cushing’s syndrome.

New data from the study suggest treatment with Recorlev in patients with the disease, which is caused by excess levels of the stress hormone cortisol, saw lasting reductions in their mean urinary-free cortisol (mUFC) and late night salivary cortisol (LNSC) levels over a six-month period.

Cushing’s syndrome occurs when a person is exposed to high levels of cortisol for a long time.

It was also found that mean urinary-free cortisol normalization with Recorlev was similar in patients suffering from diabetes.

READ: Strongbridge Biopharma shares rise on favorable Phase 3 trial results for Cushing’s syndrome drug

In response to the results, Strongbridge shares fell 3.5% to $4.97 in afternoon trade Monday.

“The subgroup analysis of Cushing’s syndrome patients with diabetes mellitus – among the more common comorbidities associated with the disease – not only shows similar levels of cortisol control compared to patients without, but also more pronounced improvements in key glycemia measures, such as hemoglobin A1c and fasting blood glucose, and other cardiovascular risk markers, such as LDL-cholesterol,” said Dr. Maria Fleseriu, a professor of Medicine and Neurological Surgery at the Oregon Health Sciences University Northwest Pituitary Center, who presented the data. 

It was also found that levels of the adrenocorticotropic hormone, which stimulates the production and release of cortisol, in a subset of patients with Cushing’s disease, jumped about two-fold from the baseline to the end of the maintenance phase.

SONICS is an open-label, Phase 3 study of Recorlev as a treatment for endogenous Cushing’s syndrome that enrolled 94 patients in North America, Europe and the Middle East.

After being treated with 150 mg of Recorlev twice daily for six months, the mean urinary-free cortisol response rate was measured to see whether it had normalized. Patients went on to continue on Recorlev for another six months to evaluate its safety and tolerability.

The data were presented at the Endocrine Society Annual Meeting in New Orleans, Louisiana (March 23-26).

With offices in Dublin and Trevose, Pennsylvania, Strongbridge Biopharma is a commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases. 

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors