- SAGE-324 (BIIB124) did not demonstrate a statistically
significant dose-response relationship on the primary endpoint in
participants with essential tremor
- No statistically significant differences were demonstrated
between any dose of SAGE-324 and placebo in the change from
baseline for the primary endpoint
Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ:
BIIB) announced topline results from the Phase 2 KINETIC 2
dose-range study of the oral investigational drug SAGE-324
(BIIB124) as a potential treatment in essential tremor (ET). The
KINETIC 2 Study did not demonstrate a statistically significant
dose-response relationship in change from baseline to Day 91 based
on the primary endpoint, The Essential Tremor Rating Assessment
Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) total
score, in participants with ET. In addition, there were no
statistically significant differences demonstrated for any dose of
SAGE-324 versus placebo in the change from baseline to Day 91 on
the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily
Living (ADL) Composite Score. Given these results, Sage and Biogen
will close the ongoing open label safety study of SAGE-324 in ET
and do not plan to conduct further clinical development of SAGE-324
in ET. The companies are evaluating next steps, if any, for other
potential indications.
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“There has been little innovation in the pharmacological
treatment of essential tremor over the past 50 years, and people
living with this debilitating condition have a pressing need for
new treatment options. We are disappointed that the results of the
KINETIC 2 Study do not support further development of SAGE-324 in
ET. We are grateful to the essential tremor community and study
investigators for their contributions to this research,” said Laura
Gault, MD, PhD, Chief Medical Officer, Sage Therapeutics. “As
always, Sage remains steadfast in our work to develop new
treatments for people suffering from brain health conditions.”
“We wish to thank the study participants and investigators who
made this important research possible. While we share in their
disappointment, we believe that the findings add to the collective
understanding of this debilitating condition and may help inform
the field on potential future research and therapeutic approaches,”
said Katherine Dawson, MD, Head of Therapeutics Development Unit,
Biogen.
KINETIC 2 Study Results
The KINETIC 2 Study was designed to evaluate the dose-response
relationship of different doses of SAGE-324 on upper limb tremor.
The study also evaluated the safety and tolerability of SAGE-324.
The primary outcome measure was TETRAS PS Item 4 Total Score at Day
91, and the primary analysis assessed the dose-response
relationship across SAGE-324 doses on this measure. Additional
analyses evaluated the change from baseline to Day 91 on the TETRAS
PS Item 4 Total Score and the secondary endpoint, TETRAS ADL
Composite Score, for each dose of SAGE-324 versus placebo.
In the study, 147 participants (129 monotherapy and 18 adjunct
therapy, on a stable dose of propranolol prior to and during the
study) were randomized in approximately equal proportions to
placebo, 15 mg, 30 mg, and 60 mg (with uptitration) for a
three-month treatment period.
- SAGE-324 did not demonstrate a statistically significant
dose-response relationship on the primary endpoint in participants
with ET.
- No statistically significant differences were demonstrated
between any dose of SAGE-324 and placebo in the change from
baseline at Day 91 on the TETRAS PS Item 4 Total Score or TETRAS
ADL Composite Score.
- Overall, there was a dose-relationship observed in the
incidence of CNS depressant treatment emergent adverse events
(TEAEs) and in the frequency of TEAEs leading to study drug
discontinuation.
- The most common TEAEs reported in any treatment group were
somnolence, dizziness, fatigue, feeling abnormal, headache, and
balance disorder. The majority of TEAEs were mild or moderate in
intensity.
About SAGE-324 / BIIB124
SAGE-324 is an investigational oral neuroactive steroid (NAS)
GABAA receptor positive allosteric modulator (PAM). NAS GABAA
receptor PAMs bind to both synaptic and extrasynaptic GABAA
receptors, enhancing inhibitory activity of the GABAergic system,
the major inhibitory neurotransmission system in the brain. GABA is
the primary inhibitory neurotransmitter in the central nervous
system and plays a critical role in maintaining balanced neuronal
activity in the brain. GABA dysregulation has been implicated in
the pathophysiology of ET. The safety and effectiveness of SAGE-324
have not been established.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company
committed to our mission of pioneering solutions to deliver
life-changing brain health medicines, so every person can thrive.
Sage developed the only two FDA-approved treatments indicated for
postpartum depression and is advancing a robust pipeline to target
unmet needs in brain health. Sage was founded in 2010 and is
headquartered in Cambridge, Mass.
Find out more at www.sagerx.com or engage with us on Facebook,
LinkedIn, Instagram, and X.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that
pioneers innovative science to deliver new medicines to transform
patients’ lives and to create value for shareholders and our
communities. We apply deep understanding of human biology and
leverage different modalities to advance first-in-class treatments
or therapies that deliver superior outcomes. Our approach is to
take bold risks, balanced with return on investment to deliver
long-term growth.
The company routinely posts information that may be important to
investors on its website at www.biogen.com. Follow Biogen on social
media – Facebook, LinkedIn, X, YouTube.
Sage Forward-Looking Statements
Various statements in this release concern future expectations,
plans and prospects, including without limitation statements
regarding: Sage’s work to develop new treatments for people
suffering from brain health conditions; plans to evaluate next
steps for the program and the mission, goals, opportunity and
potential for Sage’s business. These statements constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are neither promises nor guarantees of future
performance, and are subject to a variety of risks and
uncertainties, many of which are beyond Sage’s control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements, including the risks that: Sage
and Biogen may, jointly or individually, decide not to pursue any
further development of SAGE-324 in any indication; the results of
ongoing, planned or future clinical studies or nonclinical work
with respect to any of Sage’s product candidates may be negative
like the results announced today from the KINECTIC 2 Study of
SAGE-324 in essential tremor; results of earlier trials of any of
Sage’s other product candidates may not be replicated in ongoing or
future trials; clinical and nonclinical data Sage generates in the
course of any development program may not be sufficient to move to
the next phase of development for an indication or may not support
further development at all; additional analysis of clinical trial
results may not result in a path forward for development; Sage may
encounter adverse results or adverse events at any stage of
development that negatively impact further development or that
require additional nonclinical and clinical work which may not
yield positive results; Sage may encounter delays in initiation,
conduct or completion of ongoing or future clinical trials or
reporting of clinical trial results, including as the result of the
need to meet with regulatory authorities, or as a result of actions
arising from those meetings, that may impact Sage’s ability to meet
its expected time-lines; the FDA may not agree with Sage’s view of
the data Sage generates from its development efforts at any stage;
decisions or actions of the FDA or other regulatory agencies may
affect the initiation, timing, design, size, or progress of ongoing
or future clinical trials or the regulatory pathway for any of
Sage’s product candidates in an indication or its ability to
proceed with further development; the FDA may ultimately decide
that the design or results of completed, ongoing and planned
clinical trials, even if positive, are not sufficient for the next
phase of development or ultimately for regulatory approval of such
product candidates in any indication or of any of Sage’s product
candidates in any indications that are the focus of development
programs and plans; the internal and external costs required for
ongoing and planned activities may cause Sage to change or curtail
some of its plans; Sage may encounter technical and other
unexpected hurdles in the development and manufacture of its
product candidates which may delay its timing or change its plans;
as well as those risks more fully discussed in the section entitled
"Risk Factors" in Sage’s most recent Quarterly Report on Form 10-Q,
and discussions of potential risks, uncertainties, and other
important factors in subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Sage’s views only as of today, and should not be relied
upon as representing its views as of any subsequent date. Sage
explicitly disclaims any obligation to update any forward-looking
statements.
Biogen Safe Harbor
This news release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, relating to the
potential, benefits, safety and efficacy of SAGE-324; the potential
clinical effects of SAGE-324; the clinical development program,
clinical trials, data readouts and presentations related to
SAGE-324; the treatment of essential tremor; the potential of
Biogen’s commercial business and pipeline programs, including
SAGE-324; the anticipated benefits and potential of Biogen’s
collaboration arrangements with Sage; and risks and uncertainties
associated with drug development and commercialization. These
forward-looking statements may be accompanied by words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “hope,” “intend,” “may,” “plan,” “potential,”
“possible,” “will,” “would” and other words and terms of similar
meaning. Drug development and commercialization involve a high
degree of risk and only a small number of research and development
programs result in commercialization of a product. Results in
early-stage clinical trials may not be indicative of full results
or results from later stage or larger scale clinical trials and do
not ensure regulatory approval. You should not place undue reliance
on these statements, or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
SAGE-324; unexpected concerns may arise from additional data,
analysis or results obtained during the KINETIC Study; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen’s
drug candidates, including SAGE-324; the occurrence of adverse
safety events; the risks of other unexpected hurdles, costs or
delays; uncertainty of success in the development of SAGE-324;
failure to protect and enforce data, intellectual property and
other proprietary rights and uncertainties relating to intellectual
property claims and challenges; the direct and indirect impacts of
the ongoing COVID-19 pandemic on Biogen’s business, results of
operations and financial condition; product liability claims; and
third party collaboration risks. The foregoing sets forth many, but
not all, of the factors that could cause actual results to differ
from Biogen’s expectations in any forward-looking statement.
Investors should consider this cautionary statement as well as the
risk factors identified in Biogen’s most recent annual or quarterly
report and in other reports Biogen has filed with the U.S.
Securities and Exchange Commission. These statements are based on
Biogen’s current beliefs and expectations and speak only as of the
date of this news release. Biogen does not undertake any obligation
to publicly update any forward-looking statements, whether as a
result of new information, future developments or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20240723520261/en/
MEDIA CONTACTS: Sage Therapeutics Matthew Henson +1 917
930 7147 Matthew.Henson@sagerx.com
MEDIA CONTACTS : Biogen Jack Cox +1 781 464 3260
public.affairs@biogen.com
INVESTOR CONTACTS: Sage Therapeutics Ashley Kaplowitz +1
786 252 1419 Ashley.Kaplowitz@sagerx.com
INVESTOR CONTACTS: Biogen Chuck Triano +1 781 464 2442
IR@biogen.com
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