Sage Therapeutics is shelving one of its most important experimental drugs, after a last-ditch effort to prove it can be useful in nerve-destroying disorders ended in failure.
On Wednesday, Sage disclosed the drug, known as dalzanemdor or SAGE-718, didn’t meet any of the key goals of a mid-stage study focused on the cognitive impairment associated with Huntington’s disease. The study randomized 189 participants and found that, after 12 weeks of treatment, the cognitive function of those on SAGE-718 hadn’t changed significantly more than those given a placebo.
Sage had also tested the drug against Alzheimer’s disease and Parkinson’s disease, but those trials were not successful either. Given the latest findings, the company has chosen to stop further development of SAGE-718 and close an ongoing study evaluating its safety in Huntington’s patients.
“We are disappointed by the results … especially for the individuals and families affected by Huntington’s disease who have long awaited new treatment options,” said Sage’s CEO, Barry Greene, in a statement.
The discontinuation of SAGE-718 leaves Sage with a relatively bare research pipeline. The company has two other disclosed drugs in early human testing, and another preclinical program. An experimental drug named SAGE-324 had drawn attention from investors as well as Biogen. But it recently failed in a mid-stage tremor study, leading Biogen to hand back to Sage the rights it got through a multibillion-dollar deal.
Following this string of setbacks, Sage announced in October plans to restructure. It is reprioritizing early-stage research projects and laying off more than 165 employees — moves intended, at least in part, to free up cash so the company can operate for longer. Five of Sage’s top executives, including its chief financial officer and chief technology and innovation officer, also departed.
It was the second time in just over a year Sage turned to reorganizing. The first came in August 2023, right after the Food and Drug Administration dealt the company a hard blow. Sage had asked the FDA to approve a drug called Zurzuvae as a treatment for both postpartum depression and major depressive disorder. The agency, though, only cleared it for the former indication, which drastically limited its commercial prospects, given that major depression is much more common.
Sage and Biogen, which also holds rights to Zurzuvae, had hoped to find a way to get the drug approved in major depression. But they recently gave up that pursuit, with Sage noting how it would require “significant new investment and time.”
“We’re prioritizing our resources,” Greene told analysts on a conference call late last month.
Sage reported $569 million worth of cash, cash equivalents and marketable securities as of Sept. 30.
The company’s shares, meanwhile, have lost more than 90% of their value over the past year and a half, and currently trade at around $5 apiece.
Brian Abrahams, an analyst at the investment firm RBC Capital Markets, wrote in a note to clients that his team thought the Huntington’s trial was “very likely to fail,” and believes Sage “will likely face a long and uncertain road to achieve future profitability even with likely very significant cost cutting measures.”
This article was originally published here.
