Seelos Therapeutics Inc (NASDAQ:SEEL) said Wednesday that it has started dosing the first subjects in a Phase I Pharmacokinetic (PK) and Pharmacodynamic (PD) profile study of its SLS-002 intranasal racemic ketamine depression drug.
The New York clinical-stage biopharmaceutical company’s profile study called SLS-002-102 is a two-part, randomized, double-blind, placebo-controlled, parallel and crossover study of intranasal and intravenous ketamine which plans to enroll 62 healthy volunteers.
READ: Seelos starts initial dosing in Phase 1 study of its SLS-002 intranasal ketamine depression drug
Here are the main parameters of the study:
• Forty-eight subjects in Part A (parallel) will be randomized into four arms to receive either 30 mg, 75 mg, 90 mg of SLS-002, or placebo over 13 days.
• Fourteen subjects in Part B (crossover) will be randomized into three arms; receiving 60 mg of IV ketamine followed by 60 mg of SLS-002, 60 mg of SLS-002 followed by 60 mg of IV ketamine, or placebo over 25 days.
"This study should help clarify SLS-002's safety and tolerability across multiple intranasal doses, as well help to identify and understand any pharmacokinetic or pharmacodynamic differences compared with IV ketamine,” said CEO Raj Mehra in a statement.
“This information will assist us in confirming the dosing strategy for the planned proof of concept study in patients with major depressive disorder (MDD) suffering from Acute Suicidal Ideation and Behavior (ASIB),” he added.
On November 18, SLS-002, which is aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder at risk of committing suicide, was granted fast track designation by US regulators.
The US Food and Drug Administration granted the status for the development of the drug for the treatment of Acute Suicidal Ideation and Behavior, or 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.
Date expected in 1Q 2020
Seelos Therapeutics said that preliminary data from the study is expected in the first quarter of 2020.
After successfully completing the Phase I studies, the company plans to conduct a proof of concept study of ASIB in patients with major depressive disorder.
Technically to be a ketamine drug, it needs to have both isomers: S and R, so J&J’s Spravato can only be called esketamine since it's just one isomer. SLS-002 is both isomers, so based on studies of ketamine, each isomer hits a different receptor S-NMDA and R-AMPA. Significantly, a key Zanos paper identifies that the R isomer has no ketamine-related side effects.
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