HQ Team
July 24, 2024: An oral investigational drug jointly developed by Biogen Inc., and Sage Therapeutics Inc., failed to stop essential tremors in patients, forcing the companies to halt the trial.
The trial did not demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with essential tremor, according to a Biogen statement.
It also showed no statistically significant differences between any dose of the drug and placebo in the change from baseline to 91 days with a global tremor rating score.
The study was designed to evaluate the dose-response relationship of the drug, dubbed SAGE-324, on upper limb tremors. It was also meant to test the drug’s safety and tolerability.
Adverse events
There was a dose-relationship observed in the incidence of central nervous system depressant treatment-emergent adverse events and the frequency of these events leading to the discontinuation of the drug.
The most common adverse events reported were drowsiness, dizziness, fatigue, feeling abnormal, headache, and balance disorder.
The majority of Treatment Emergent Adverse Events were mild or moderate in intensity, according to the statement.
“Given these results, Sage and Biogen will close the ongoing open-label safety study,” and do not plan to conduct further clinical development of the drug to treat essential tremors, according to the statement.
‘Disappointed’
The companies are evaluating the 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,” said Laura Gault, MD, PhD, Chief Medical Officer, Sage Therapeutics.
“People living with this debilitating condition have a pressing need for new treatment options. We are disappointed with the results,” she said.
Tremor is the most common movement disorder and results from an interaction between pathological neural control and the frequency response of the limb.
Parkinson’s Disease
The two leading conditions that cause tremors in the upper limb are Essential Tremor and Parkinson’s disease, according to the National Institutes of Health.
Other conditions that can cause tremors include dystonia, cerebellar ataxia, traumatic brain injury, stroke, and multiple sclerosis.
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