Strongbridge Biopharma plc Announces Publication of Secondary Endpoints Data from Phase 3 SONICS Study of RECORLEV (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in the Journal, Pituitary

~ RECORLEV (levoketoconazole) Treatment Resulted in Significantly Improved Clinician-Assessed Signs and Symptoms and Patient-Reported Outcomes of Cushing’s Syndrome ~

DUBLIN, Ireland and TREVOSE, Pa., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that secondary endpoint results from the Phase 3 SONICS study of RECORLEV (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome were published online in advance of print publication in the peer-reviewed journal, Pituitary, the official publication of the Pituitary Society and the Growth Hormone Research Society.

“People with Cushing’s syndrome often experience a variety of problematic signs, symptoms, and comorbidities related to excess cortisol, testosterone or both,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “The SONICS study provided important evidence that RECORLEV treatment was associated with durable improvements in several of the more common and bothersome signs and symptoms of the syndrome, including those that most commonly affect women, such as hirsutism and acne, which are related to increases in testosterone produced by the adrenal glands.”

The manuscript, entitled “Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing’s syndrome,” includes analyses demonstrating that treatment with RECORLEV led to significant improvements in Cushing’s syndrome signs and symptoms, patient-reported quality of life (QoL) outcomes, depression symptoms, and testosterone levels.

• Significant mean improvements from baseline were noted at end of the Maintenance phase (Month 6) for acne, hirsutism (females only), and peripheral edema.
• These improvements were observed as early as Day 1 of Maintenance for hirsutism, the end of Month 1 of Maintenance for acne, and Month 4 of Maintenance for peripheral edema.
• By Month 3 of Maintenance, significant mean improvements in patient-reported QoL outcomes were observed and by Month 6, symptoms of depression had improved.
• A reduction in mean free-testosterone in women, consistent with improvements in clinical signs of hyperandrogenism was observed, and a modest increase in mean free-testosterone in men was observed.
• RECORLEV was generally well-tolerated; the most commonly reported adverse events during the dose-titration and maintenance phases were nausea (32%) and headache (28%).