Seelos Therapeutics, Inc. (Nasdaq: SEEL) announced its year-end 2021 business and clinical update. In the second half of 2021, Seelos said it had achieved several major clinical and financial milestones and continued to make progress on its multiple clinical-stage development programs. As of year-end 2021, Seelos had $78.7mm of cash.
SLS-002 (intranasal racemic ketamine)
- In July, Seelos began dosing patients in Part 2 of the registration-directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
- In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
- In October, Seelos presented a poster titled “A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide”, at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.
“In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I’ve seen in my career,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program’s registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson’s disease-focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.”