Seelos Therapeutics swings and misses on ALS drug study

Seelos Therapeutics swings and misses on ALS drug study

The drug failed to achieve “statistical significance” on the endpoints of the study.

Biotech company Seelos Therapeutics Inc. (Nasdaq: SEEL) told investors on Tuesday that its drug SLS-005 (IV trehalose) failed a study to treat amyotrophic lateral sclerosis or ALS causing the stock to plunge. The study was designed to evaluate SLS-005, a low molecular weight disaccharide, in decreasing the slope of the ALS Functional Rating Scale (ALSFRS-R) slope.

The stock price plummeted from roughly 93 cents to 37 cents during the day on the news. It recovered somewhat to close on Tuesday at 65 cents

Seelos said the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS), by showing a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%). Also, there was an imbalance of deaths/death equivalents observed in the study, with more events seen in the SLS-005 group compared to the placebo, yet all were considered unrelated to the study drug. On a positive note, it showed a potential signal of efficacy in a pre-specified subgroup (ERF).

“The HEALEY platform is designed to detect signals of efficacy and we believe the observed signal and success probability is competitive to other recently FDA-approved therapies for ALS which also failed to achieve statistical significance when measured for function and mortality on similar primary and efficacy endpoints,” said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. “We plan to request a meeting with the FDA to discuss potential next steps for the program and will continue our potential partner discussions.”

ALS is a group of rare neurological diseases mainly involving the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. It is an incurable disease that results in a slow and painful death.

Seelos has had a mixed track record in its studies. In September, Green Market Report wrote that Cantor Fitzgerald downgraded the stock when its ketamine drug SLS-002 failed to achieve meaningful signals for its primary endpoint. The company’s investigational psychedelic therapy was aimed at alleviating suicidal symptoms in adults diagnosed with major depressive disorder. However, the 147-patient Phase 2 trial failed to meet the enrollment target and was cited by Seelos as the primary reason for the trial’s setback.

Charles Duncan, a Cantor analyst, subsequently downgraded Seelos from “Overweight” to “Neutral.” Duncan pointed out that the company’s financial limitations could obstruct its ability to effectively conduct and complete such trials in the future.

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