Strongbridge Biopharma plc Announces Positive and Statistically Significant Top-Line Results from the Pivotal Phase 3 LOGICS Study of RECORLEV (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome

~ LOGICS Study Met Primary Endpoint with High Statistical Significance; Results at the End of the Randomized-Withdrawal Phase of the Study Demonstrated that Withdrawing Patients to Placebo Resulted in a Loss of Cortisol Response in 54.5 Percent (p=0.0002) More Patients than the RECORLEV (levoketoconazole) Arm ~

~ RECORLEV (levoketoconazole) was Generally Well Tolerated with a Safety and Tolerability Profile Comparable to the Profile Observed in the Phase 3 SONICS Study ~

~ Company Anticipates Submitting a New Drug Application (NDA) for RECORLEV (levoketoconazole) to the FDA in the First Quarter of 2021; If Approved, Expects to Launch RECORLEV in the First Quarter of 2022 ~

~ Company to Host Conference Call Today at 8:30 a.m. ET ~

DUBLIN, Ireland and TREVOSE, Pa., Sept. 08, 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 positive and statistically significant top-line results from its multinational, Phase 3, double-blind, placebo-controlled, randomized-withdrawal LOGICS study evaluating RECORLEV (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.

“We are delighted to announce the positive and statistically significant top-line results of the LOGICS study, which add to the growing body of evidence supporting the potential of RECORLEV (levoketoconazole) as an effective and well tolerated cortisol synthesis inhibitor to treat Cushing’s syndrome. We believe that these results, coupled with the previously reported positive results from our Phase 3 SONICS study, will support a New Drug Application in the U.S., which we plan to submit to the Food & Drug Administration in the first quarter of 2021,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “On behalf of Strongbridge, we would like to thank the many patients, investigators, collaborators, and employees who have contributed to our RECORLEV Phase 3 clinical program, particularly to our more recent study participants who remained committed to completing the LOGICS study despite the ongoing COVID-19 pandemic.”