A poster presented at ENDO 2021 appears to show promise for a new treatment aimed at patients with Cushing’s syndrome.
The poster, presented by Strongbridge Biopharma, plc, a global commercial-stage biopharmaceutical company, announced that detailed results from the previously reported Phase 3 LOGICS study of RECORLEV® (levoketoconazole) in patients with endogenous Cushing’s syndrome were presented in a poster session at ENDO 2021, being held virtually from March 20 – 23, 2021.
“We are pleased to share these detailed results of the LOGICS study with the scientific community, which build upon the robust and positive data from our Phase 3 SONICS study and further demonstrate the overall treatment benefit of RECORLEV in adult patients with endogenous Cushing’s syndrome,” says Fredric Cohen, MD, chief medical officer of Strongbridge Biopharma. “Together with SONICS, these LOGICS data demonstrate substantial evidence of RECORLEV efficacy and safety and serve as the basis of our New Drug Application (NDA), which was recently submitted to the U.S. Food and Drug Administration (FDA). We remain confident that, if approved, RECORLEV may be an important new treatment option for patients with endogenous Cushing’s syndrome.”
The poster presentation, which further evaluated the safety and efficacy of RECORLEV by comparing the effect of withdrawing RECORLEV treatment to placebo versus continuing treatment with RECORLEV on the cortisol therapeutic response established during open-label RECORLEV therapy, highlighted the following:
- As previously reported, LOGICS met its primary endpoint with statistical significance. At the end of the double-blind randomized-withdrawal (RW) phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol (mUFC) response as compared with those who remained on RECORLEV (p = 0.0002). Sensitivity analyses supported the primary endpoint inference.
- The key secondary endpoint of mUFC normalization at the end of the RW phase was also statistically significant with 45.5 percent more patients treated with RECORLEV maintaining mUFC normalization in the active arm than the placebo arm (p = 0.0015).
- In the RW phase, median time on RECORLEV was 55.5 days (range, 16–62) and on placebo was 23.0 days (range, 16–62 days), indicating rapid loss of cortisol control upon RECORLEV cessation.
- The secondary endpoints of mean changes from the RW baseline to the end of the RW phase for total and LDL-cholesterol were significantly different (p<0.01) between treatment groups, with mean treatment differences of 37.1 and 25.1 mg/dL, respectively.
- During the titration-maintenance phase, mean change in body mass index (BMI) was -1.13 kg/m2. Mean change in BMI from RW baseline to end of RW phase was -0.65 kg/m2 in the RECORLEV group, and +0.59 kg/m2 in the placebo group (treatment difference: -1.2 kg/m2; P<0.0001).
- Among 80 subjects treated with RECORLEV in both phases combined, the most commonly reported adverse events (occurring in 15% or more subjects) were nausea, hypokalemia, headache, hypertension, and diarrhea. Five percent of subjects had a serious adverse event considered to be drug related. Nineteen percent had an adverse event that contributed to drug discontinuation; no subjects discontinued due to adverse event in the RW phase.
On March 2, 2021, the Company announced it had submitted an NDA for RECORLEV for the treatment of endogenous Cushing’s syndrome to the FDA. The submission is supported by previously reported positive and statistically significant results of the SONICS and LOGICS trials: two Phase 3 multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat adults with endogenous Cushing’s syndrome.