More than two-thirds of patients reported sleepiness and more than a third experienced dizziness. Overall, 62% of patients needed to decrease the amount of medicine they took and 38% dropped out of the study altogether.
The high sleepiness and dizziness rates “would make it very challenging for the product to be a commercial success,” Mizuho Securities analyst Vamil Divan said in a report to clients. “A few movement disorder specialists we have spoken to have indicated that sedation rate above 20% for a drug in this condition would be problematic.”
On the stock market today, Sage stock slipped 2.5% to 74.68. Biogen stock fell 2% to 262.80.
Sage Stock Falls On Side Effects
Sage and Biogen aimed to improve involuntary shaking due to the neurological disorder.
On day 29, patients who received the drug known as SAGE-324 showed a 36% reduction in upper limb tremors vs. a 21% decline for the placebo group.
In more serious patients, those who received the treatment had a 41% decline in upper limb tremors vs. an 18% reduction for the placebo group.
“The (effectiveness) results were more impressive statistically, suggesting the drug may have a more clear role in that population,” Divan said.
He kept his neutral rating and 81 price target on Sage stock.
Generally Consistent Side Effects
The companies expected side effects due to the high doses they tested, Divan said.
“However, we wonder if the rates of side effects were higher than what had been expected,” he said.
That’s likely what toppled Sage stock on Monday. On a year-to-date basis, Sage stock is down 14.1%.
But the companies said adverse events were generally consistent with what they’d seen to date for SAGE-324. The most common treatment-related side effects occurred in roughly 10% of patients. That included sleepiness, dizziness, balance disorder, diplopia, — seeing two images of one object — motor speech disorder and gait disturbance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
YOU MAY ALSO LIKE: