Strongbridge Biopharma plc Announces Dosing of First Four Patients in LOGICS, a Second Global Phase 3 Study of RECORLEV™ (l...
April 02 2018 - 7:30AM
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.”
ABOUT THE LOGICS STUDYLOGICS 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 ClinicalTrials.gov and reference Identifier: NCT03277690.
About Endogenous Cushing’s SyndromeEndogenous
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 BiopharmaStrongbridge
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 StatementsThis
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.
Contacts:
Corporate and Media Relations Elixir Health
Public Relations Lindsay Rocco +1 862-596-1304
lrocco@elixirhealthpr.com
Investor RelationsU.S.:The Trout Group Marcy
Nanus +1 646-378-2927 mnanus@troutgroup.com
Europe:First HouseMitra Hagen Negård+47 21 04 62
19strongbridgebio@firsthouse.no
USA 900 Northbrook Drive Suite 200 Trevose,
PA 19053 Tel. +1 610-254-9200 Fax. +1 215-355-7389
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