Sage Therapeutics and Biogen have disclosed topline results from the Phase II KINETIC 2 study, in which SAGE-324 (BIIB124) showed no significant benefit in treating essential tremor (ET).
An oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM), SAGE-324, was administered to participants in various dosages to determine its impact on upper limb tremor.
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The study aimed to establish a dose-response relationship and assess the safety and tolerability of the drug.
The change in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 Total Score at day 91 was the primary outcome measure of the trial.
It involved a total of 147 subjects, divided approximately equally among placebo, 15mg, 30mg, and 60mg doses of SAGE-324.
According to the findings, the KINETIC 2 study did not demonstrate a statistically significant dose-response relationship based on the primary endpoint.
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By GlobalDataAdditionally, no significant differences were observed for any dose of SAGE-324 compared to placebo concerning changes from baseline to day 91 on both the TETRAS PS Item 4 Total Score and the TETRAS Activities of Daily Living (ADL) Composite Score.
The study did, however, observe a dose-relationship in the incidence of the central nervous system (CNS) depressant treatment-emergent adverse events (TEAEs) and in the frequency of TEAEs leading to study drug discontinuation.
Somnolence, fatigue, dizziness, feeling abnormal, balance disorder and headache were the most commonly reported TEAEs across treatment groups.
Based on these outcomes, Sage and Biogen announced plans to terminate the ongoing open-label safety study of SAGE-324 in ET and will not pursue further clinical development of the drug for this indication. The companies are now considering potential future steps for SAGE-324 in other indications.
Sage Therapeutics chief medical officer Laura Gault said: “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.”
