Seelos Therapeutics Inc (NASDAQ:SEEL) continues to be "extremely pleased" with the side-effect profile of its SLS-002 drug candidate for acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD) and PTSD, the firm said, as it announced additional data from Phase 1 studies.
Some of the key highlights of the interim vital signs adverse events (AEs) data from the study, which involves 104 subjects, included that no serious adverse events (SAEs) related to vital signs were observed.
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The biopharma group also highlighted that, in the open-label study of SLS-002-101, only five out of 42 subjects, at a 60mg dose experienced mild and transient AEs. Increases in blood pressure and heart rate are known to be side effects of ketamine.
Additional data from the Phase I studies are expected to be released early in the second quarter of 2020 once all dose cohorts are unblinded and evaluated, the firm said.
Seelos also announced that it has completed its Type C meeting with the US Food and Drug Administration (FDA), as scheduled.
This meeting was to discuss the protocol design for a study of the SLS-002 candidate for ASIB in patients with Major Depressive Disorder (MDD).
"Earlier this month, we completed our scheduled face to face Type C meeting with the FDA for input and feedback on a potential clinical study of SLS-002 for acute suicidal ideation and behavior in patients with major depressive disorder,” Raj Mehra, the chairman and CEO of Seelos noted in the statement.
“We continue to be extremely pleased with the side effect profile of SLS-002 to date and will continue to work closely with the agency on the design of the protocol for the next study," he added.
Shares in New York nudged up 3.7% to $0.49.
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