The trial’s findings were presented in a poster titled, “Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome: Improvements in Clinical Signs and Symptoms, Patient-Reported Outcomes and Associated Biochemical Markers in the Phase 3 SONICS Study,” at the 2019 American Association of Clinical Endocrinologists (AACE) Annual Scientific and Clinical Congress, held recently in Los Angeles.
The Phase 3 trial (NCT01838551), known as SONICS, was launched by Strongbridge to evaluate the safety and efficacy of Recorlev for the treatment of patients with Cushing’s syndrome.
Its primary goal was to reduce cortisol levels in patients’ urine after six months of Recorlev maintenance therapy. Secondary endpoints, or goals, included decreasing the risk of heart disease, which is high among people with Cushing’s.
SONICS’ top-line results, announced in August 2018, showed the trial had already reached its primary and secondary goals. An extended evaluation showed that Recorlev continued to be well tolerated and to induce clinically meaningful improvements in the long-term.
The new data presented at the AACE included additional secondary endpoints of SONICS, such as assessing the effects of Recorlev on signs and symptoms of Cushing’s, and patient-reported outcomes of quality of life.
According to the new findings, Recorlev improved Cushing’s clinical symptoms, including acne, hirsutism (excess of body and facial hair in women), and peripheral edema (swelling in the legs, feet, or ankles), among the 61 patients who completed the six-month maintenance therapy.
In female patients, Recorlev also led to a decrease in the mean levels of free testosterone, which was consistent with improvements in clinical signs of hyperandrogenism (a disorder in which women produce an excessive amount of male hormones). Conversely, in male patients Recorlev treatment led to a mild increase in the mean levels of free testosterone.
Moreover, Recorlev treatment led to significant improvements in patient-reported quality of life, including symptoms of depression, from the start to the end of the six-month maintenance therapy.
Recorlev was generally well-tolerated by patients. The most common adverse events reported included nausea (31.9%), headaches (27.7%), peripheral edema (19.1%), high blood pressure (17.0%), and fatigue (16.0%). From the 14 serious adverse events reported during the study, only four were related to the use of Recorlev.
In total, 12 patients (12.8%) of the 94 initially enrolled in SONICS had to stop treatment due to adverse events.
“The SONICS data presented at AACE highlight Strongbridge’s commitment to developing effective treatments that translate into meaningful, real-world outcomes for patients,” Fredric Cohen, MD, chief medical officer of Strongbridge Biopharma, said in a press release.
“People with Cushing’s syndrome often experience negative physical effects as well as emotional challenges brought on by the condition. These results are the first to demonstrate that treatment with Recorlev significantly improves many of those symptoms, including acne, excess male-pattern hair growth in women, peripheral edema, and symptoms of depression. Further, these findings provide important insights from a patient perspective that may inform clinical decision-making for this population,” Cohen said.