Psychedelics

- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced dosing of the first patients in its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.

(PRNewsfoto/Seelos Therapeutics, Inc.)

"The dosing of the first patients in our study could not come at a more crucial time as there still remains a high unmet need for a therapy to address the symptoms of suicidality," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "We will continue to train and add trial sites and look forward to sharing the open-label data from the first 16 patients once dosing, safety follow up, and data analysis have been completed."

The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (intranasal racemic ketamine) in addition to standard of care on the symptoms of Major Depressive Disorder and suicidality in patients who are assessed to be at imminent risk of suicide.

The design of the study is as follows:

  • The study is comprised of two parts:
    • Part A is an open-label, non-placebo study of 16 patients receiving 90mg doses of SLS-002
    • Part B aims to enroll approximately 120 patients to be randomized 1:1 to receive standard of care plus either 90mg doses of SLS-002 or an intranasal placebo.
    • Part B will commence immediately after the 16 th patient in Part A is dosed.
  • Study duration will be 16 days (approximately seven days inpatient and nine days outpatient), dosed twice weekly (five total doses), and safety follow up for two weeks.
  • The primary endpoint to be evaluated will be the change from baseline on the:
    • Montgomery -Åsberg Depression Rating Scale (MADRS) at 24 hours after first dose.
  • The secondary endpoints to be evaluated will be the change from baseline on the:
    • Clinical Global Impression of Severity for Suicidal Ideation and Behavior Scale (CGIS-SI/B) at 24 hours after the first dose,
    • Sheehan-Suicidality Tracking Scale (S-STS) at 24 hours after the first dose,
    • Patient Global Impression of Severity for Suicidal Ideation and Behavior Scale (PGIS-SI/B) at 24 hours after the first dose, and
    • CGIS-SI/B, S-STS, PGIS-SI/B, and MADRS at Day 16.

The first data readout is expected to be available upon completion of the study with the first 16 patients in the Part A open-label portion.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality, the expected timing for the first data readout for the Proof of Concept study, Seelos' continued training and expectations around the addition of trial sites for the Proof of Concept study, the design of the Proof of Concept study, the number of patients to be enrolled in Part B of the Proof of Concept study, the expected timing for commencing Part B of the Proof of Concept study, the expected duration of the Proof of Concept study and the primary and secondary endpoints to be evaluated in the Proof of Concept study. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the Proof of Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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SOURCE Seelos Therapeutics, Inc.

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Lobe Sciences Announces the Expansion of its Patent Portfolio with International Filings

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Nirvana Life Sciences Inc. (Nirvana or the "Company") (CSE: NIRV) a western Canadian based life sciences company aimed at developing psychedelic therapeutic medicines, including non-addictive chronic pain and relapse preventing products is pleased to report filing of a patent for D7-h.

Nirvana Life Sciences Inc. Logo (CNW Group/Nirvana Life Sciences Inc.)

Nirvana Life Sciences Inc. is pleased to announce it has recently filed a patent for the deuterated form of 7-hydroxymitragynine (D7-h), the active compound in kratom responsible for the opiate like effect the plant produces when ingested. Opioid use disorder and opioid addiction remain at epidemic levels in Canada , the US and worldwide.  In 2021, there were 7560 apparent opioid-related deaths in Canada , which is equivalent to 20 people dying each day, and was greater than the average number of Canadians killed daily in motor vehicle collisions. This number continues to grow, with the PHAC projecting as many as 2400 opioid-related deaths in each quarter of 2022.

The use of Kratom in Southeast Asia has been documented back for at least 150 years and is described both as having a stimulant effect for use in hard day labor when fresh leaves are chewed and an analgesic and relaxing effect if brewed into a tea. In the past decade or more, recognition and the use of kratom has grown in Canada , the United States , and the world at large. Although use has increased, there still remains a lack of research regarding kratom and the various different components within it that are active when taken. One important observation that has been made is that people who take kratom do not see the same respiratory decrease that is often the cause of death and overdose in people who take opiates. This is due to 7-hydroxymitragynine being a partial mu opioid agonist, unlike Fentanyl and oxycodone which are full mu opioid agonists and are known to have depressant effects on respiration.

With so many people affected by opioid use disorder, opioid addiction, and the risk of death from using these substances, research into alternative pain formulations is more than ever necessary. In order to create a medicine that has the potential to truly help people with addictions and those living with chronic pain, it is important to have a deep understanding of how these compounds work in the brain and body. Scientists and doctors have long used deuterated drugs to help track how a drug moves through the brain and body, in order to gain a better understanding of its mechanisms.

A deuterated drug is a small molecule medicinal product in which one or more of the hydrogen atoms contained in the drug molecule have been replaced by its heavier stable isotope deuterium. Because of the kinetic isotope effect, deuterium-containing drugs may have significantly lower rates of metabolism, and hence a longer half-life, as can be seen with Deutetrabenazine, a deuterated version of tetrabenazine, developed by Teva and approved by the FDA in 2017 for the treatment of chorea associated with Huntington's disease. Applications of the deuterium isotope effect have increased over time, and it is now applied extensively in mechanistic research focused on the metabolism of drugs, as well as with many other studies that focus on safety, efficacy, tolerability, bioavailability, and pharmacokinetics (PK).

Nirvana Life Sciences Inc. knows the importance of creating a deuterated form of 7-hydroxymitragynine (D7-h) in order to gain a better understanding of the mechanisms of this compound in the body, including knowledge about safety, bioavailability, efficacy, pharmacokinetics (PK) and more. It is our hope that researchers at Nirvana Life Sciences Inc. and elsewhere will be able to use D7-h to fill the gap in knowledge that exists about kratom, to then create safer and more effective alternatives to opiates for people struggling with addiction and chronic pain.

Robert August , lead chemist and Head of Innovation with Nirvana Life Sciences Inc., stated "With research in chronic pain and addiction, and developing treatments for these, being at the forefront of the mission of Nirvana Life Sciences Inc., we are hopeful to see how this development may change not just science, but the lives of many people." We couldn't agree more and are thrilled to add D7-h to our growing portfolio of novel compounds, formulations and processes focused on chronic pain, addiction and trauma.

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that can provide healthier outcomes for patients who live with chronic pain and/or have battled with addiction. Nirvana believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction. Nirvana's team, consisting of leading researchers from around the globe, will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually

Forward Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as "forward-looking statements") within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

SOURCE Nirvana Life Sciences Inc.

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