Strongbridge Biopharma plc (NASDAQ:SBBP) rose Monday, after the company presented detailed results from pivotal Phase 3 LOGICS study of RECORLEV® (levoketoconazole) for the treatment of endogenous cushing's syndrome at the 2021 Annual Meeting of the Endocrine Society.
Strongbridge is an Irish company with offices in Pennsylvania.
Said Chief Medical Officer Frederic Cohen, "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,
"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:
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 At the end of the double-blind randomized-withdrawal (RW) phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol (mUFC) response as compared with those who remained on RECORLEV (p = 0.0002).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.
SBBP shares tacked on 19 cents, or 5.6%, to $3.56.
