Xeris Biopharma Holdings (NASDAQ:XERS) Inc revealed the results of the extended evaluation of levoketoconazole, or Recorlev, from the Phase 3 SONICS study published in the European Journal of Endocrinology.
The study evaluated longer-term effects of Recorlev on cortisol levels, biomarkers of Cushing's syndrome (CS) comorbidities, clinical signs and symptoms of CS, and quality of life.
Additionally, the manuscript reported findings from pituitary adenoma imaging in the SONICS study.
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As for the key study findings, 60 patients entered extended evaluation (EE) at month six; 61% (or 33 out of 54 with data) exhibited normal mean urinary free cortisol (mUFC).
At months nine and 12, respectively, 55% (27/49) and 41% (18/44) of patients with data had normal mUFC.
In addition, reductions in late-night salivary cortisol (LNSC) and random serum cortisol were observed at month six, nine, and 12.
The study also revealed that mean fasting glucose, total and LDL-cholesterol, body weight, body mass index, abdominal girth, Cushing QoL, and BDI-II scores improved from study baseline at months nine and 12.
New findings
Meanwhile, female patients reported significant mean decreases in hirsutism score at all assessments, while mean testosterone levels decreased significantly at month six and were maintained throughout the EE period.
Of 31 patients with tumor measurements at baseline and month 12 or follow-up, the largest tumor diameter was stable in 27 (87%) patients, decreased in one, and increased in three.
Of the 46 patients that completed month 12; four (6.7%) discontinued during EE due to adverse events. The most common adverse events in EE were arthralgia, headache, hypokalemia, and QT prolongation (6.7% each)
No patient experienced ALT or AST of greater than three times ULN, a QTcF interval of more than 460 milliseconds, or adrenal insufficiency during EE, the company said.
"The results from this extended evaluation of the SONICS study provide important new evidence in support of Recorlev and will help inform clinicians' decisions and individualization of medical therapy for patients with endogenous CS," said Dr Ken Johnson, senior vice president, global development and medical affairs at Xeris.
"I would like to extend our gratitude to all the investigators, study coordinators and patients who participated in the SONICS trial program. Their contributions are integral in our mission to improve outcomes for patients with this rare, debilitating, and life-threatening condition."
First time longer-term effects are reported from EE phase
The study represents the first time the longer-term effects of levoketoconazole are reported from the EE phase of the previously published SONICS study.
EE study participants received maintenance treatment with levoketoconazole with assessments scheduled at month nine and month 12. The majority, 65%, received levoketoconazole doses of 600 mg/day or less at the start of the EE period. Forty-six or 77% of patients completed the study (month 12).
Recorlev received Food and Drug Administration marketing approval in December 2021. The initial approval was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated US population with Cushing's syndrome.
The SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase.
LOGICS, a double-blind, placebo-controlled randomized-withdrawal study that met its primary and key secondary endpoints, confirmed the efficacy and safety of Recorlev in normalizing and maintaining therapeutic response compared with placebo.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients' lives by developing and commercializing innovative products across a range of therapies.
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