Seelos Therapeutics asserts that the second part of its Phase 2 trial of SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in major depressive disorder would have met its primary endpoint if the study had been able to reach full enrollment. According to the company, the trial enrolled only 147 out of an anticipated 220 patients “due to financial constraints.” Seelos said that based on reduction of depression symptoms in patients using SLS-002 compared to placebo, the company plans to continue development of the nasal spray, which is delivered via Aptar Pharma’s Bidose Liquid System (BDS).
The FDA granted SLS-002 Fast Track designation for the treatment of acute suicidal ideation in MDD in November 2019. Seelos announced the initiation of the Phase 2 trial in January 2021 and announced results from the first part of the study in May 2021.
Seelos Chief Medical Officer Tim Whitaker commented, “The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care. We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps. In addition, we want to thank the study participants, as well as the clinical trial sites and staff, for their expert and careful care of these high-risk study patients.”
Chairman and CEO Raj Mehra said, “We believe these data are remarkable. We expect to move forward with our development of SLS-002 after the end of Phase 2 meeting with the FDA. The improvements with SLS-002 were robust and continued to improve across efficacy scales with 5 doses over the two-week treatment period. In addition to the data on efficacy, the differentiated and well-tolerated safety profile of SLS-002 highly underscores this product candidate’s uniqueness and potential for the treatment of ASIB in MDD. We look forward to advancing this therapy toward a potential first approval for an important unmet need for this patient population, especially considering that 2022 experienced the highest number of suicides in US history.”
Read the Seelos Therapeutics press release.
