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Strongbridge Biopharma plc Announces Dosing of First Four Patients in LOGICS, a Second Global Phase 3 Study of RECORLEV™ (levoketoconazole) in Endogenous Cushing’s Syndrome

DUBLIN, Ireland and TREVOSE, Pa., April 02, 2018 (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 that the first four patients have been dosed in LOGICS, a second global Phase 3 study evaluating the efficacy and safety of RECORLEV™ (levoketoconazole), a next-generation cortisol synthesis inhibitor, for the treatment of endogenous Cushing’s syndrome.

“The initiation of the LOGICS study marks an important milestone for the RECORLEV Phase 3 clinical development program and brings us one step closer to our goal of providing a potential new treatment option to the Cushing’s syndrome community,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “In the LOGICS study, we expect to randomize approximately 35 patients, of which approximately one-half will have previously completed SONICS, our first global Phase 3 study evaluating the efficacy and safety of RECORLEV. We look forward to reporting top-line results from SONICS in the middle of this year and LOGICS in the first quarter of 2019.”

“Cushing’s syndrome is a severe endocrine disorder that can have devastating long-term consequences when left untreated. Although surgery is typically the initial treatment choice for both pituitary and adrenal Cushing’s and remission rates are generally good, the risk of recurrence, especially in Cushing’s disease, remains high and can be seen up to decades after an initial diagnosis, underscoring the need for safe and effective, long-term therapeutic options,” said Maria Fleseriu M.D., F.A.C.E., professor and director at the Oregon Health & Science University NW Pituitary Center and a principal investigator of the LOGICS study. “RECORLEV is a promising, next-generation cortisol synthesis inhibitor that could possibly have a more favorable efficacy, safety, and tolerability profile than the currently-available treatments for hypercortisolemia. Potential new treatments, such as RECORLEV, could address significant unmet needs in the current therapeutic landscape. I am pleased to be participating in the LOGICS study, which will hopefully advance our overall understanding of Cushing’s syndrome and ultimately improve treatment outcomes for patients.”

LOGICS is a placebo-controlled, double-blind, randomized-withdrawal study that will randomize approximately 35 patients with Cushing’s syndrome in more than 11 countries in North America and Europe. Approximately one-half of randomized subjects will have previously completed SONICS. The primary endpoint is to compare the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the urinary free cortisol (UFC) therapeutic response previously established during open-label levoketoconazole therapy. Following a screening period of up to 13 weeks, the study will be conducted in three treatment phases: an open-label dose titration and maintenance phase of 14 to 19 weeks for subjects naïve to levoketoconazole or otherwise not receiving a stable therapeutic dose of levoketoconazole over the 12 weeks prior to enrolling; a randomized-withdrawal phase of 8 to 9.5 weeks during which subjects receive blinded treatment with active drug or placebo; and a restoration period of 8 to 9.5 weeks, during which all subjects receive their therapeutic dose of blinded levoketoconazole and placebo, to prevent disclosure of the prior randomized therapy.  The total duration of study participation, including the screening period, can range from approximately 16 to 51 weeks.

For more information on the LOGICS study, please visit and reference Identifier: NCT03277690.

About Endogenous Cushing’s Syndrome
Endogenous Cushing’s syndrome (CS) is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. Most people with CS have a variety of signs and symptoms – many of which, when they occur by themselves, are common and do not necessarily point to an underlying disease; this makes recognition of CS difficult. Common presenting symptoms include weight gain or obesity, fatigue, muscle weakness, headaches, mood or sleep disturbances, facial rounding or redness, excess body hair growth in women or baldness in men, thinned skin with stretch marks, easy bruising and other skin changes including acne, mood or sleep disturbances and irregular periods or loss of libido.  Patients are often found by their doctors to have new-onset or worsening of high blood pressure, abnormal levels of blood lipids, such as cholesterol, polycystic ovaries and abnormal blood glucose or diabetes. People with uncontrolled disease are seriously ill and have a 2- to 4-fold higher mortality rate than age- and gender-matched controls, mainly due to metabolic and cardiovascular complications. Treatment options for CS include surgery, radiation therapy, and medical treatment. Cushing’s syndrome most commonly affects adults ages 20-50 and is more prevalent in females, accounting for about 70 percent of all cases.

About Strongbridge Biopharma
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s commercial portfolio within its rare neuromuscular and rare endocrine franchises includes KEVEYIS®(dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis, and MACRILEN™ (macimorelin), the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency. The Company’s rare endocrine franchise also includes a clinical-stage pipeline of therapies: RECORLEV™ (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing’s syndrome, and veldoreotide, a next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge’s strategy, plans, outcomes of product development efforts, status and results of clinical trials and objectives of management for future operations. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.


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Source: Strongbridge Biopharma