Ketamine Ushering in New Era in the Pharmacology Therapies for Neurological Disorders

PALM BEACH, Fla., July 27, 2022 /PRNewswire/ — For years, ketamine was known for its use as an anesthetic or as a recreational drug. Its ability to provide quick and safe sedation saved many lives during the Vietnam war and is still the preferred anesthetic in battlefield situations. It can be used to induce a kind of trance-like state which wipes away pain. Ketamine may turn out to be more than an anesthesia drug or an illegal means of getting high. While more research needs to be done, recent studies point to its ability to relieve treatment-resistant depression, act as an anti-suicide drug, possibly reduce pain, and even assist in PTSD. “In slightly more than a decade, the emergence of ketamine’s rapid antidepressant effects has been viewed by some experts in the field as arguably the most important psychiatric discovery in half a century.” said an article on the NIH Natural Library of Medicine website. The NIH continued saying: “Neurological disorders are the leading cause of disability and the second leading cause of death worldwide. The increasing social and economic burdens of neurological disorders are driven by global population growth and aging. Depression is a common psychiatric symptom in numerous neurological disorders. It is also a risk factor for Alzheimer’s disease (AD) and other dementias, Parkinson’s disease (PD), and stroke. The rapid-acting and sustained antidepressant actions of (R,S)-ketamine for severe depression was accidentally discovered. Interestingly, (R)-ketamine has greater potency and longer-lasting antidepressant-like effects than (S)-ketamine in rodents. Importantly, its side effects in rodents and humans are lower than those of (R,S)-ketamine and (S)-ketamine. Furthermore, (R)-ketamine could elicit beneficial actions in various rodent models of neurological disorders, including PD, multiple sclerosis (MS), and stroke.” Active companies in the markets this week include: Silo Pharma, Inc. (OTCQB: SILO), Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), atai Life Sciences N.V. (NASDAQ: ATAI), Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS).

An article in the Green Market Report added: “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. Research and development activities for ketamine companies is on the rise as well. 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.'”

Silo Pharma, Inc. (OTCQB: SILO) BREAKING NEWS: Silo Pharma Announces Positive Results from its Topically Administered Formulation of Ketamine – Silo shows reversal of allodynia and hyperalgesia using its selected formulation and partnered, patented delivery system – Silo Pharma, Inc., a development-stage biopharmaceutical company today announced that its topically administered Ketamine reached a positive end point in an animal study.

Silo’s formulation reduced mechanical allodynia and hyperalgesia at both the pre-and post-dosing time points, and mechanical hyperalgesia was reduced on day seven at the pre-dose time point. These results indicate that the dosing of Ketamine using a patent protected delivery system with Silo Pharma’s partner, Zylo Therapeutics, yielded positive results in reducing neuropathic nerve pain in a small animal study.

Eric Weisblum, CEO of Silo Pharma, commented, “These positive results of our study show that Silo is able to successfully formulate and deliver ketamine topically at reduced dosage to achieve its endpoint of pain reduction. This data is extremely promising for patients suffering from Fibromyalgia and Rheumatoid Arthritis. Additionally, I am delighted to report that Day seven and Day nine scores averaged zero (no erythema or swelling present) for all groups, which bodes extremely well for our planned toxicology study.”

To read this full press release and other news for SILO, visit: https://ir.silopharma.com/news-releases/

Other recent developments in the markets include:

Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), a global leader in the development and delivery of psychedelic therapies, recently announced the first successful dosings in the Phase 1 Clinical Study entitled “A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers.” The study is being conducted at PARC Clinical Research at the Royal Adelaide Hospital in Australia.

Field Trip’s first molecule in development, FT-104, is a prodrug of 4-OH-DiPT, a synthetic serotonin-2A (5HT2A) agonist. Pre-clinical data suggests FT-104 has a potency and pharmacology similar to psilocybin, but with a significantly shorter half-life of approximately three hours. Based on the FT-104 pre-clinical profile projecting a reduced treatment burden, and promising results from the early psilocybin therapy studies conducted at leading academic centers, the Company believes that FT-104 could provide a rapid, safe and effective therapy for depression and other mental health conditions when delivered in conjunction with psychotherapy.

atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently reported financial results for the quarter ended March 31, 2022 and provided a business update.

“We made great progress in the first quarter on our mission to achieve clinically meaningful behavioral change in people living with mental health disorders – seeing strong momentum across our three strategic pillars. We dosed the first subject in our Phase 1 KUR-101 trial and launched our fourth drug discovery program, Invyxis. In addition, we initiated a usability study of Psyber in patients receiving ketamine treatment, further advancing our ongoing digital support programs,” said Florian Brand, Chief Executive Officer & Co-Founder of atai.

“The first quarter of 2022 continued with strong execution of our clinical pipeline. We anticipate several clinical milestones in 2022 and beyond, including data from the Phase 2 proof-of-concept study of PCN-101 as a potential at-home-use therapy in treatment resistant depression (TRD). We also anticipate results from a relative bioavailability study comparing subcutaneous formulation of PCN-101 to existing IV formulation, and additional Phase 1 readouts, including GRX-917, DMX-1002, and KUR-101. Finally, we expect Phase 2 trial initiations for GRX-917 and RL-007, as well as Phase 1 initiations for EMP-01 and VLS-101 during 2022 and RLS-01 in the first half of 2023. It’s a testament to our phenomenal team that we anticipate to have 10 compounds in the clinic.” said Srinivas Rao, Chief Scientific Officer & Co-Founder of atai.

Cybin Inc. (NYSE American: CYBN) (NEO:CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, recently announced that, through its wholly-owned subsidiary Cybin IRL Limited, it has completed the acquisition of a Phase 1 N,N-dimethyltryptamine (“DMT“) study (the “Acquisition“) from Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon“). This DMT study, which is the largest to date, is expected to accelerate the clinical development path of CYB004, Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders, by approximately nine months. The Company previously announced details of the Acquisition on June 7, 2022.

“With the closing of this transaction we are well on our way to advancing CYB004 through Phase 1 development and gathering essential safety and dosing optimization data that will inform the clinical path forward for this important molecule,” said Doug Drysdale, Chief Executive Officer of Cybin. “Cybin now has multiple clinical-stage programs ongoing that we believe will contribute significantly to a greater understanding of the potential of psychedelics to provide therapeutic relief to patients who suffer with a variety of mental health issues.”

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced that it will release financial results for the second quarter 2022, and provide an update on recent business developments on 4 August 2022.

The management team will host a conference call at 8:00am ET (1:00pm UK) on 4 August. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.

A live webcast of the call will be available on COMPASS Pathway’s website at: Second Quarter 2022 Financial Results. The webcast will also be available on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

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