Strongbridge Biopharma plc Completes Target Enrollment of 90 Patients in the Phase 3 SONICS Study Evaluating RECORLEV™ (lev...
June 27 2017 - 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 it has met its
enrollment target of 90 patients in the Phase 3 SONICS study
evaluating the safety and efficacy of RECORLEV™ (levoketoconazole),
a next-generation cortisol synthesis inhibitor, for the treatment
of endogenous Cushing’s syndrome. Based upon strong interest in the
SONICS study at the end of screening, a small number of additional
potential study participants remain in screening and will be
allowed to enroll, if qualified.
“We would like to sincerely thank our
investigators, their clinical teams, and, most importantly, all of
the patients from many countries around the globe for their
continued dedication and participation in the SONICS study,” said
Fredric Cohen, M.D., chief medical officer of Strongbridge
Biopharma. “We currently still have patients in screening for
SONICS due to the high level of interest and demand in the
study. Although we have reached target enrollment, we are
pleased to extend the study for a brief period to accommodate those
in screening who qualify. This will enable us to report top-line
results in the second quarter of 2018,” Dr. Cohen added.
“The need for a safe and effective,
next-generation cortisol synthesis inhibitor, such as RECORLEV, in
the treatment of Cushing’s syndrome is substantial. Through
achieving target enrollment in the SONICS study, we are one step
closer to better understanding the clinical value of RECORLEV and
potentially bringing a new therapeutic treatment option to this
community,” said Matthew Pauls, president and chief executive
officer of Strongbridge Biopharma. “Because we strongly believe in
the potential of RECORLEV to become a best-in-class therapy, and as
previously announced, we have strengthened our Phase 3 development
plan to include LOGICS, a nine-week, placebo-controlled study,
which will complement the long-term SONICS study. We anticipate
availability of top-line data from the LOGICS study in the third
quarter of 2018,” Pauls added.
SONICS and LOGICS are multinational Phase 3
studies designed to evaluate the safety and efficacy of RECORLEV
when used to treat endogenous Cushing’s syndrome. SONICS is a
single-arm, open-label study conducted in three treatment phases.
Patients titrate to a therapeutic dose in the first phase and are
maintained at the therapeutic dose for six months in the second
phase, the end of which marks the primary efficacy time point. A
six-month extended evaluation is included for long-term safety
evaluations. LOGICS uses a placebo-controlled, double-blind,
randomized-withdrawal design. Approximately 35 patients with
Cushing’s syndrome will be randomized in LOGICS, of which
approximately one-half will have previously completed SONICS.
Together, the SONICS and LOGICS studies will include the
participation of approximately 100 clinical research sites in over
20 countries in North America, Europe and the Middle East.
For more information on the SONICS study, please
visit ClinicalTrials.gov and reference identifier: NCT01838551.
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 first commercial product is KEVEYIS®
(dichlorphenamide), the first and only FDA-approved treatment for
hyperkalemic, hypokalemic, and related variants of Primary Periodic
Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S.
through August 7, 2022. In addition to establishing this
neuromuscular disease franchise, the Company has a clinical-stage
pipeline of therapies for rare endocrine diseases. Strongbridge's
lead compounds include 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, with potential
additional applications in Cushing's syndrome and neuroendocrine
tumors. Both RECORLEV and veldoreotide have received orphan
designation from the U.S. Food and Drug Administration and the
European Medicines Agency. For more information, visit
www.strongbridgebio.com.
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, anticipated investment, 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 Relations
U.S.:
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com
Europe:
First House
Mitra Hagen Negård
+47 21 04 62 19
strongbridgebio@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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