Exhibit 99.1
Sage Therapeutics and Biogen Announce Topline Results from Phase 2 KINETIC 2 Study of SAGE-324
(BIIB124) for the Treatment of Essential Tremor
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SAGE-324 (BIIB124) did not demonstrate a statistically significant
dose-response relationship on the primary endpoint in participants with essential tremor |
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No statistically significant differences were demonstrated between any dose of
SAGE-324 and placebo in the change from baseline for the primary endpoint |
CAMBRIDGE Mass.
July 24, 2024 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.
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.