Seelos Therapeutics Inc (NASDAQ:SEEL) said Wednesday that it has started dosing the first subjects in a Phase I drug-drug interaction (DDI) study to show that its SLS-002 intranasal ketamine depression drug can be safely administered with two commonly prescribed antidepressants.
The New York clinical-stage biopharmaceutical company’s study called SLS-002-101 is a single-center, open-label study of SLS-002 dosed in combination with two commonly prescribed antidepressants.
The study plans to enroll 48 healthy volunteers, studied over 14 days, randomized into two treatment arms and dosed with a combination of SLS-002 and either, venlafaxine ER or sertraline.
Seelos stock was up nearly 1% at $0.88 in morning trade.
READ: Seelos stock soars after its SLS-002 intranasal ketamine depression drug granted fast track status by FDA
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile, drug-drug interaction, and safety measures of SLS-002.
“The initial dosing of SLS-002 is a very significant event for Seelos and in the development of intranasal racemic ketamine. We hope to initially demonstrate that SLS-002 can be safely dosed in combination with subjects’ current use of two commonly prescribed antidepressants,” said Seelos Therapeutics CEO Raj Mehra.
“The initiation of the DDI study will be closely followed by an additional Phase I study measuring pharmacokinetic, pharmacodynamics, and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine,” he added.
Date expected in 1Q 2020
Preliminary data from the study is expected in the first quarter of 2020.
On successful completion of the Phase I studies, Seelos plans to conduct a Phase II proof of concept study of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder MDD.
On November 18, Seelos Therapeutics’ SLS-002 intranasal ketamine depression drug aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide, was granted fast track designation by US regulators.
The US Food and Drug Administration (FDA) granted the status for the development of the drug for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with major depressive disorder.
The FDA's fast track program is designed to speed up the development and review of new medicines for the treatment of serious conditions where there is an unmet need.
Johnson & Johnson’s (NYSE:JNJ) J&J’s nasal spray SPRAVATO and Seelos’ SLS-002 nasal spray both have formulations of ketamine, with subtle differences. J&J’s nasal spray contains the esketamine compound, which is one half of the ketamine compound. However, Seelos Therapeutics’ nasal form of racemic ketamine is made of two mirror-image molecules and is likely to be given at a lower dose because it is far more potent.
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