Seelos Therapeutics Inc (NASDAQ:SEEL) said Thursday that it was scheduled to meet with the Food and Drug Administration to design a proof-of-concept study linked to its promising SLS-002 intranasal ketamine depression treatment aimed at patients with post-traumatic stress disorder (PTSD) at imminent risk of suicide.
The New York clinical-stage biopharmaceutical company’s SLS-002 ketamine treatment is also aimed at patients with major depressive disorder (MDD), characterized by chronic feelings of sadness, worthlessness and irritability.
Investors cheered the progress surrounding the ketamine-based depression treatment, sending Seelos stock up nearly 4.1% to $2.85 in pre-market trade.
“Seelos will be meeting with FDA to design and initiate a Proof-of-Concept (PoC) study in patients with post-traumatic stress disorder at imminent risk of suicide,” Seelos Therapeutics CEO Raj Mehra said in a statement. “This study is in addition to our already scheduled PK/PD and Drug-Drug Interaction studies.”
Seelos plans to begin its pharmacokinetics and pharmacodynamics study in the second half of 2019 and engage the FDA in discussions for the next steps for a pivotal trial after that data. After it completes the study and reviews the data, Seelos plans to request a post-Phase 2 meeting with the FDA to discuss trial design requirements for a pivotal study.
Key new hire
As part of a corporate update Seelos told investors it was tapping Dr Warren W Wasiewski as the company’s new chief scientific officer. He has more than 35 years of experience as a physician focused on pediatric neurology. He also has extensive clinical and regulatory experience at companies involved in the neurology, pediatric and orphan disease space.
Update on pipeline development
Seelos will webcast its presentation at the Jefferies 2019 Healthcare Conference at 8 am (ET) on Friday, June 7. Investors can access the presentation by using this link: http://wsw.com/webcast/jeff118/seel
SLS-002 intranasal racemic ketamine
Seelos is seeking guidance from the FDA in a scheduled Type C meeting (face to face) over the summer to design and initiate a PoC study in patients with Suicidality-PTSD
- This study is in addition to its PK/PD and DDI study that is scheduled for dosing in healthy volunteers in late third quarter
- The study plans to utilize the Sheehan-Suicidality Tracking Scale (S-STS) to measure the safety and efficacy of intranasal racemic ketamine
- In addition to the S-STS, and usual safety measures and scales, the company intends to utilize the following "gold standard" in the assessment of PTSD: the PTSD Checklist for DSM-5 (PCL-5), the Clinically Administered PTSD Scale (CAPS) to measure symptoms of PTSD, and the Montgomery-Åsberg Depression Rating Scale (MADRS) to stratify and to measure the severity of possible co-morbid depression symptoms
- The company has other late-stage pipeline products like SLS-005 which target rare orphan diseases. Dr Wasiewski will lead the collaboration with Team Sanfilippo Foundation, to advance the SLS-005 program in Sanfilippo syndrome patients and will spearhead the program in oculopharyngeal muscular dystrophy (OPMD).
- This study has now been expanded to be a combined Phase 2b/3, multicenter, enriched enrollment, case-controlled withdrawal trial which will determine the safety and tolerability of Trehalose IV in Sanfilippo A and B patients along with efficacy based on well-known biomarkers, functional outcomes, neuro-cognitive assessments and quality of life measurements
- On May 21, the decision was taken to expand inclusion of Sanfilippo type C and D patients as well as type A and B patients who do not meet the trial entry criteria into a separate expanded patient access study
For a small company, Seelos has multiple assets in development with massive potential. It is focused on central nervous system, neurological and psychiatric disorders.
Contact Uttara Choudhury at [email protected]