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Seelos Therapeutics’ experimental ALS drug SEEL.O failed to meet the primary endpoint of a mid-stage trial, the company said Tuesday, the latest study failure in a field littered with failures clinics.
Shares of the New York company plunged about 52% to 44 cents, hitting a record high.
The drug SLS-005, tested on 120 patients, failed to show a statistically significant improvement in motor function and reduce mortality in patients with ALS, or amyotrophic lateral sclerosis, compared to a placebo.
The company said it will discuss next steps with the U.S. Food and Drug Administration and plans to conduct further analyzes of the trial when it receives the full data set. She said the drug showed a “potential signal of effectiveness” in the study.
ALS affects 16,000 to 32,000 people in the United States and has long eluded researchers searching for an effective treatment.
Still, the FDA has approved a handful of drugs in recent years, such as Biogen’s Qalsody BIIB.O and Amylyx Pharmaceuticals’ Relyvrio AMLX.O .
“We believe the observed signal and likelihood of success are competitive with other recently FDA-approved therapies for ALS, which have failed to reach statistical significance,” said Raj Mehra, chief executive officer of Seelos.
Earlier this month, Amylyx said it was considering pulling Relyvrio, which failed to slow disease progression in a late-stage trial, off the market.
Other recent failures in ALS drug development include the failure of the trial by Denali Therapeutics DNLI.O and partner Sanofi SASY.PA , and the negative vote by FDA advisors for the Brainstorm Cell Therapeutics treatment
BCLI.O.
ALS is a rare disease that can affect the nerve cells in the brain and spinal cord responsible for muscle movements, leading to progressive paralysis and death.