Suicide is a difficult subject that often gets pushed to the side because, well, it's depressing. Rates of suicide in the U.S. are at a more than 20-year high, according to a Princeton research article. Often suicides aren't reported on the news because of a fear of suicide contagion. This research suggested "spread of suicide-related thoughts and behaviors through exposure to sensationalized and harmful content is a well-recognized phenomenon."
As a result it is surprising to learn that according to the research, "Annually, there are nearly 500,000 Emergency Department visits for self-harm, and rates of such injuries have risen by more than 39% from 2001 to 2017. Furthermore, national survey data indicate that the total number of Americans at risk for suicide is even greater; more than 10.5 million Americans experience serious thoughts of suicide each year."
One company willing to tackle such a difficult subject is the biotech company Seelos Therapeutics (SEEL) . The company has designed a study for acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD) beginning in the fall of 2020 using Intranasal Racemic Ketamine (SLS-002). Seelos is planning to initiate this proof of concept study in two parts: Part A is an open-label study of 16 patients, and will be followed by Part B which is a double blind, placebo-controlled study of approximately 120 patients.
Raj Mehra, Ph.D., Chairman and CEO of Seelos said at the time, "It is heartening to see that all intranasal doses were judged to be generally safe and well tolerated, and the resolution of dissociative side-effect among all doses by the one hour timepoint for this group mean affords that this therapy is truly differentiated, which enables Seelos to evaluate SLS-002 in indications beyond ASIB, such as first line MDD."
The company's goal is to have the drug available in hospitals to treat suicidal patients when they are in the emergency room. Currently most suicidal patients enter the hospital where they are stabilized for a short time and then are often transferred to a mental hospital. However, without insurance many patients are often released back into society and having had no real resolution to the problem.
A study by Dr. Kyle Lapidus, et al. at Mt Sinai in 2014 has shown significant improvement in depressive symptoms at 24 hours after ketamine compared to a placebo. The company found that its intranasal ketamine was well tolerated with minimal adverse side effects.
Currently, suicidal patients are often given anti-depressant drugs that actually come with a warning that it may cause suicidal thoughts. These drugs are also slow acting, whereas patients respond to this ketamine within hours. Seelos sees this as an unmet opportunity and one that it is willing to take on. While other companies are being judged on the relative ease with which ketamine is handed out at clinics, Seelos says it wants no part of the storefront ketamine world.
In addition to its ketamine work, Seelos was granted Orphan Drug Designation (ODD) for SLS-005 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) from the FDA. Seelos said its Phase IIb/III trial plans to enroll 160 patients with either familial or sporadic ALS in a double-blind placebo-controlled trial. SLS-005 was previously granted Orphan Drug Designation from the FDA and the European Medicines Agency (EMA) for Sanfilippo syndrome, spinocerebellar ataxia type 3 (SCA3) and oculopharyngeal muscular dystrophy (OPMD).
While lots of focus has been heaped on clinic companies serving up ketamine treatments, Seelos is quietly building its reputation as a solution to a terrible problem. It's a wonder how many lives could be saved if they were given this drug at a time of dire need.
