Seelos Therapeutics, Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced interim data from its Phase I study of Intranasal Racemic Ketamine (SLS-002).
Interim data from study SLS-002-101 demonstrated that 60mg of SLS-002, when administered as a monotherapy and in combination with an oral antidepressant, was generally safe and well-tolerated. All adverse events (AEs), except for one, were deemed mild or moderate. All AEs were transient in nature, consistent with the known profile of the drugs, and all resolved without medical intervention. The interim results from the study have not revealed any new or unique safety signals, there were no serious adverse events (SAEs), and only one of 42 subjects discontinued the trial prematurely (withdrawal on the last day of dosing due to an AE but completed the evaluation).
“This study is highly encouraging in regard to the side effect profile of SLS-002,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We look forward to releasing data throughout the quarter as additional study cohorts are completed and evaluated.”
Study SLS-002-101 is a single-center, open-label study which enrolled 42 healthy volunteers, studied over 14 days, randomized into two treatment arms and dosed with a combination of 60mg of SLS-002 and either, venlafaxine ER or sertraline. The primary objective of this study was to evaluate the pharmacokinetic (PK) profile, drug-drug interaction (DDI), and safety measures of SLS-002.
Seelos recently received Fast Track designation for SLS-002 for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
Additional data from the ongoing Phase I studies of SLS-002 to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine is expected throughout the first quarter of 2020.