Clinical-stage biopharma psychedelics company Seelos Therapeutics Inc. has dosed the first patients in a Phase 1 study with healthy adult Japanese and non-Asian participants to compare the safety and pharmacokinetic PK profiles of proprietary intranasal racemic ketamine SLS 002
The company has previously consulted and received an endorsement to conduct the ethno-bridging trial on behalf of the FDA and Japan s Pharmaceuticals and Medical Devices Agency.
Seelos chairman and CEO Dr. Raj Mehra says that the study is an important first step in evaluating the potential of the novel drug in patients around the world. Our market research shows a high need for a therapy with both antidepressant and anti-suicidal effects. The trial will assess dosage and administration, sample size, inclusion and exclusion criteria, endpoints and blood sampling, with data expected to inform the inclusion of Japanese subjects in the design of a global trial in patients with Major Depressive Disorder MDD at imminent risk of suicide.
SLS 002 holds two Investigational New Drug IND applications for the treatment of acute suicidal ideation and behavior in MDD and PTSD.
The compound was originally derived from a Javelin Pharmaceuticals Inc. program with 16 clinical studies involving approximately 500 subjects. After meeting with the FDA, a clinical development program includes two parallel Phase 1 studies that will be followed by pivotal registration studies.
Seelos is looking to provide a therapy with SLS 002 for the treatment of suicidality in the US, considering there were over one million visits to emergency rooms for suicide attempts in the country in a year 2019 Photo: Benzinga edit with photo by RODNAE Productions on Pexels and Doc James on Wikimedia Commons.
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