– 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
CAMBRIDGE, MA, USA I July 24, 2024 I 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.
- 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.
SOURCE: Biogen
Post Views: 6,031
– 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
CAMBRIDGE, MA, USA I July 24, 2024 I 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.
- 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.
SOURCE: Biogen
Post Views: 6,031
