Seelos Therapeutics (NASDAQ:SEEL) Inc's share price plummeted by 66% pre-market after the company announced that its phase II study for SLS-002, a treatment for adults with major depressive disorder at risk of suicide, failed to meet its primary goal.
The primary goal, or 'endpoint', is a key measure used to determine the success of a treatment in clinical trials. In this case, and because of financial constraints, not enough patients were recruited to meet this crucial benchmark.
In all 220 people were supposed to take part in the evaluation, 73 fewer than needed.
This smaller sample size meant researchers couldn't statistically prove the drug's effectiveness within 24 hours after dosing, as initially planned.
However, Seelos believes the results would have been statistically significant if the study had reached full enrolment.
Despite the setback, the study did show some promising signs. The treatment led to "early and persistent" reductions in symptoms of depression and suicidal thoughts, according to the Montgomery-Åsberg Depression Rating Scale, a standard tool for measuring the severity of depression.
Tim Whitaker, chief medical officer of Seelos, said the results indicate the treatment's potential to address a significant unmet need in mental health care. The company plans to discuss next steps with the U.S. Food and Drug Administration (FDA).
The study's failure to meet its primary endpoint raises questions about the future of SLS-002, but the observed benefits may offer a glimmer of hope for a treatment area in desperate need of innovation.
Ahead of the bell, the stock was off 66 cents at 34 cents.