Seelos Archives - Green Market Report

Dave HodesApril 5, 2022
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8min66600

Most people in the psychedelics industry believe that the growing superstar of psychedelic medicines is psilocybin—the “psychedelic du jour” as one scientist put it to Psychedelia.

But ketamine is quickly changing that perception.

Ketamine was introduced to the market in 1970 as a U.S. Food and Drug Administration (FDA) approved anesthetic after clinical trials that began following its formulation in 1962. More than 20,000 research papers have been published on ketamine since 1965, mostly about its use as an anesthetic, according to a study

From the 1970s through the 1990s, ketamine usage increased both medically and recreationally.

In the late ‘90s and early 2000s, ketamine began to show evidence as an effective antidepressant. Since 2006, 225 random controlled trials, 51 meta-analyses, and more than 565 reviews have reported on ketamine’s effectiveness at alleviating refractory depression and anxiety, and more recently, suicidality and pain management.

Ketamine is also being investigated for use with eating disorders (though researchers say that more empirical research is needed).

The biggest advantage of ketamine is that it is generally believed to be an FDA-approved drug for psychedelic therapy. But an FDA alert issued in February stated that ketamine is not FDA-approved for the treatment of any psychiatric disorder, blurring the understanding of exactly how it should be used. 

However, the “S” form of ketamine, which is derived from ketamine and known as Johnson and Johnson’s Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults, and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.

What’s more, questions about the efficacy of ketamine have arisen from research that suggests ketamine use can create psychiatric, cardiovascular, neurological, and other side effects. 

But those issues haven’t stopped its growing popularity as a treatment for depression and other neurological disorders. It makes ketamine a target for more research. And that is happening.

For example, in November 2021, Yale Department of Psychiatry researchers were awarded a $2 million grant from the Michael J. Fox Foundation for Parkinson’s Research to conduct a clinical trial of ketamine to treat depression in people with Parkinson’s disease. It is the first investigation of ketamine as an antidepressant in a neurological disorder.

Research and development activities for ketamine companies is on the rise as well.

PharmaTher (OTCQB: PHRRF) (CSE: PHRM), created to develop and commercialize specialty ketamine pharmaceuticals for mental health, is planning a Phase 3 clinical study to allow for FDA approval of Ketarx, their ketamine treatment for Parkinson’s disease.

Seelos Therapeutics (US:SEEL) is currently pursuing a two-part Phase 2 clinical trial for intranasal delivery of ketamine, with results expected in December 2022.

Atai Life Sciences N.V. (Nasdaq: ATAI), a clinical-stage biopharmaceutical company, announced in January that the FDA has given Investigational New Drug (IND) clearance to conduct a clinical study of ketamine. Atai plans to initiate the study early this year through its platform company, Perception Neuroscience.

Field Trip Health, (NASDAQ: FTRP) the largest provider of psychedelic-assisted therapies in Canada, continues to open ketamine clinics for therapeutic use across the U.S. and Canada, with the goal of opening up to 75 ketamine clinics by 2023 to join Field Trip clinics that are already operating in such locations as downtown New York and Los Angeles (both cities also have multiple private ketamine therapy businesses not associated with Field Trip). 

Field Trip began operations in March 2020. They recently applied to the Canadian government to legally use psilocybin and MDMA-assisted therapies under Canada’s Special Access Program.

The use of ketamine as a fast-acting antidepressant in treatment-resistant patients has boosted the interest in the mechanism of action both in psychiatry and in the wider area of neuroscience. “Ketamine can make a genuine leap forward in the therapy of depression,” a study concluded. “Its clear effectiveness in reducing symptoms of depression and suicidal ideation, either after a single administration, or especially when administered repeatedly in addition to another antidepressant, is an extremely promising factor in the treatment of depression. Furthermore, research on new molecules designed to reproduce the rapid and sustained antidepressant effects of ketamine, without its adverse effects, allows us to assume that a new era in the pharmacology of antidepressants has already begun.”


StaffNovember 24, 2021
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4min980

Seelos Therapeutics, Inc. (Nasdaq: SEEL) is buying the worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX. Seelos said it is paying roughly $9 million in cash and stocks. Seelos said it plans to evaluate the sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The company also said in a statement that the Food and Drug Administration (FDA) has granted Wafermine Orphan Drug designation for the treatment of CRPS.

“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”

Eddy Lee, Chairman and CEO of iX Biopharma added, “We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine and the other sublingual ketamine products,” said . “Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”

$20 Million Note

In addition to the acquisition, Seelos announced the placement of a $22 million senior secured convertible note and shares of Seelos common stock to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds. Seelos said it plans to use the proceeds for general corporate purposes and to advance the development of its product candidates.

“2021 has been a volatile year for the biotech sector and this financial commitment from the team at Lind further strengthens our balance sheet and provides for additional future funding,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The team at Lind has been a terrific partner for us and their creative and innovative funding solutions are thoughtfully and strategically designed to fit the needs of their partners. We are proud to once again work together, and we look forward to the continued execution of our ongoing and future studies.”


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