Clinical-stage biopharma firm Seelos Therapeutics has dosed the first patients in its registrational ‘Proof of Concept’ study to evaluate SLS-002 (intranasal racemic ketamine) for acute suicidal ideation and behaviour in major depressive disorder patients.
According to experimental studies, ketamine can potentially treat refractory depression and suicidality rapidly and effectively.
The study is a multi-centre, two-part clinical trial, with an open-label cohort followed by a randomised, double-blind, placebo-controlled study.
It will analyse the efficacy, safety, and tolerability of repeat doses of SLS-002 along with the standard of care (SOC) on major depressive disorder and suicidality symptoms in patients who are at imminent risk of suicide.2
Seelos chairman and CEO Raj Mehra said: “The dosing of the first patients in our study could not come at a more crucial time as there still remains a high unmet need for a therapy to address the symptoms of suicidality.
“We will continue to train and add trial sites and look forward to sharing the open-label data from the first 16 patients once dosing, safety follow up, and data analysis have been completed.”
The study will have two parts. In the open-label, non-placebo Part A study, 16 patients will be given 90mg doses of SLS-002.
On dosing the last patient in Part A, Part B will be initiated which will have around 120 patients who will randomly receive SOC plus either 90mg doses of SLS-002 or a placebo.
The study will be conducted for 16 days with seven days inpatient and nine days outpatient. The patients will be dosed twice weekly to receive a total of five doses and followed up for two weeks.
The change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 24 hours after the first dose will form the study’s primary endpoint. Other secondary endpoints will also be assessed.
Seelos plans to conduct first data readout on concluding Part A of the study.