Seelos Therapeutics Conducts Initial Dosing of Phase 1 DDI Study

Seelos Therapeutics (NASDAQ:SEEL) announces it has dosed the first patients in its Phase 1 DRug-Drug Interaction (DDI) Study, SLS-002-101.

As quoted in the press release:

SLS-002-101 is a single-center, open-label study of SLS-002 dosed in combination with two commonly prescribed antidepressants. This 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. The primary objective of this study is to evaluate the pharmacokinetic (PK) profile, DDI, 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 Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The initiation of the DDI study will be closely followed by an additional Phase I study measuring PK, pharmacodynamics (PD), and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine.”

Preliminary data from this study is expected in the first quarter of 2020.

Upon successful completion of the Phase I studies, Seelos plans to conduct a Phase II Proof of Concept (PoC) study of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

Click here to read the full press release.