Seelos Therapeutics Inc (NASDAQ:SEEL) announced promising interim data from a Phase 1 study of its ketamine-based depression treatment.
The study showed 60 milligrams of Intranasal Racemic Ketamine, known as SLS-002, to be safe and well-tolerated when administered as a monotherapy or in combination with an oral antidepressant.
“This study is highly encouraging in regard to the side effect profile of SLS-002,” CEO Raj Mehra said in a statement. “We look forward to releasing data throughout the quarter as additional study cohorts are completed and evaluated.”
READ: Seelos to seek FDA guidance on Phase III trial for SLS-002 ketamine depression drug
The open-label study enrolled 42 healthy volunteers and over two weeks, they received 60mg of SLS-002 and either venlafaxine ER or sertraline. The idea was to evaluate the safety of SLS-002 as well as the drug-drug interaction.
All adverse events from the study, with one exception, were considered mild or moderate, and all were resolved without medical intervention.
Seelos previously received Fast Track designation from the US Food and Drug Administration for SLS-002 as a treatment for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.
More data from the study is expected to be released in the first quarter of 2020, the company said.
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