Seelos Therapeutics Inc (NASDAQ:SEEL) said Wednesday that it was on track with its SLS-002 intranasal ketamine depression drug, aimed at patients with major depressive disorder (MDD) at risk of committing suicide.
While providing its first-quarter business update, the New York company which is focused on the central nervous system, neurological and psychiatric disorders, stressed the importance of mental health during the coronavirus (COVID-19) pandemic
“As we work through this crisis, we are acutely aware of the issues that may grow and likely persist in the aftermath,” said Seelos in a statement.
New York was nearing 5,500 coronavirus deaths as of Tuesday. It is expected to be the hardest-hit state, in terms of raw numbers.
The company said history has shown the need for mental health treatment “surges” during tragedies that cause “a major loss of human life, financial disruptions and unemployment.”
Seelos said addressing Acute Suicidal Ideation and Behavior (ASIB) was the company’s “top priority” and the ongoing pandemic has “heightened its importance” as healthcare providers work to develop a novel treatment for patients.
“Currently, the work on all our programs is progressing as scheduled, and the Food and Drug Administration (FDA) has been very accommodating by providing virtual and telephonic interactions for guidance in lieu of face-to-face meetings,” said CEO Raj Mehra.
“We have a talented and extremely experienced team driven to advance our programs and look forward to continuing to update our shareholders."
Seelos expects to release additional safety data on the Phase I studies of SLS-002 in the second quarter, and details from the Type C meeting with the FDA.
- Phase I dosing for all 104 patients was completed as scheduled
- Preliminary safety data to date has been highly encouraging. There have been no serious adverse events, the super-majority of the adverse events have been “mild and transient in nature” and all subjects completed the study
- Seelos is on schedule to lock and unblind the Phase I data in the second quarter of 2020 and will release additional data once unblinded
- The Type C meeting with the FDA successfully concluded in March and provided a path forward for the proof of concept study in ASIB in MDD
- In March, Seelos received a letter from the European Medicines Agency with guidance to design an open-label, non-placebo controlled, Phase IIb/III pivotal study for treating patients with Type A and B versions of Sanfilippo syndrome, a childhood disorder that triggers fatal brain damage.
- Seelos is in discussions with the FDA regarding the use of Sanfilippo syndrome natural history data as a control for a pivotal study in the US.
- Requests for Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for SLS-005 in Sanfilippo syndrome have been submitted to the FDA.
- Seelos is also working on finalizing a protocol for a pivotal study in Oculopharyngeal Muscular Dystrophy (OPMD) and expects to provide details after interacting with the FDA.
SLS-004 and SLS-007
- Seelos is continuing with pre-clinical work on both the Parkinson’s disease programs
- Details of the protocol for SLS-007 will be released on approval by the company’s scientific advisers
- Seelos has begun spadework for a Pre-Investigational New Drug (IND) application, this time for SLS-008, a treatment it plans for pediatric esophagitis, which affects fewer than 200,000 people nationwide
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive