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Allied Files Provisional Patent for Psilocybin Therapeutic Invention Seeking Drug Indication for Mental Health Depression and Anxiety Applications

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Allied Corp.
·15 min read
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KELOWNA, British Columbia, March 18, 2021 (GLOBE NEWSWIRE) -- Allied Corp. ("Allied") (OTCQB: ALID), an international medical cannabis company focused on creating and providing targeted psilocybin and cannabinoid health solutions to address today’s medical issues, is pleased to announce that it has submitted a provisional patent for the Allied therapeutic formulation and treatment regimen involving a prescription drug followed by a prophylactic daily drug formulation. These two products together administered under a novel treatment regimen is intended to be tested through the Allied clinical trial infrastructure to seek a drug indication for general depression and anxiety.

The provisional patent submitted is entitled: COMPOSITIONS AND FORMULATIONS OF PSILOCYBIN AND CANNABINOIDS AND METHODS OF THEIR USE TOGETHER FOR TREATING MENTAL HEALTH DISORDERS AND IMPROVING MENTAL HEALTH.

This provisional patent contemplates the full scope treatment of general depression and anxiety with a proprietary Rx prescription medication followed by a daily prophylactic dose of proprietary medicinal compositions. This includes a proprietary dosing and therapeutic regimen of psilocybin, additional functional mushrooms and cannabinoid therapeutics.

Among the various aspects of the present invention contemplated in the provisional patent submission are compositions, formulations, methods for modulating endocannabinoid system activity, for modulating neuro-steroid biosynthesis, and for modulating neurotransmission, and methods for treating mental health disorders and improving mental health, using synergistic combinations of psilocybin, cannabinoids, and other active agents, provided in distinct daily dosing regimens.

The content contemplated in the provisional patent submission describes the real world pharmaceutical formulations that Allied intends to research via human clinical trials in order to seek a drug indication.

“This further deepens our product pipeline beyond our current products under provisional patent. We are excited to put our best physicians and scientists to work to prove the efficacy of this novel therapeutic approach to full scope treatment of mental health conditions,” says Calum Hughes, CEO of Allied. “Currently, treatment options for mental health disorders consist generally of psychotherapy, pharmacotherapy, and direct brain intervention. We at Allied aim to develop an additional evidence-informed treatment option that physicians will be able to prescribe to the people who most need it.”

Some educational information regarding the current need for Allied’s products and the research foundation for Allied’s approach

Psychotherapy may take various forms including cognitive behavioral therapy (CBT), exposure therapy, eye movement desensitization and reprocessing (EMDR), and numerous forms of talk therapy (often, paired together with a pharmacological agent). CBT is generally believed to be fully effective for approximately a third of patients with mood disorders, with another third receiving partial benefit, and a last third receiving no benefit at all. Even for those who receive benefit, psychotherapy must be continued for years or even decades. In long-term studies of patients using psychotherapy to deal with symptoms of post-traumatic stress disorder (PTSD), 10-15 percent of patients were considered to have fully recovered; the remainder either dropped out or required further treatment. Because of the extended length of time typically required to see a clinically significant benefit, and because it is usually received in a one-on-one setting with a clinical professional, psychotherapy for many patients is difficult or prohibitively expensive to access or obtain consistently. (Jackobsen et al., SSRIs versus placebo in patients with major depressive disorder. A systematic review, BMC Psychiatry (2017)17:58.)

Pharmacological therapies provide a similar spectrum of benefit; i.e., although some patients benefit, many patients find only partial relief, and many no relief at all. And for many, while relief may come, it comes accompanied by unacceptable medication-related side effects. (Jackobsen et al., SSRIs versus placebo in patients with major depressive disorder. A systematic review, BMC Psychiatry (2017)17:58.)

First-line pharmacological treatment for most mental health disorders (including depression, panic and anxiety disorders, obsessive compulsive disorder, phobias, bulimia, adjustment disorder, and PTSD), typically involves use of selective serotonin reuptake inhibitors (SSRIs). SSRIs block the reabsorption (i.e., reuptake) of serotonin into neurons, thereby increasing levels of serotonin in the brain. However this may require weeks or months to produce therapeutic effects, while also significantly increasing the risk of serious adverse events. And once prescribed, a proportion of patients can continue to take them throughout their entire lives. (Jackobsen et al., SSRIs versus placebo in patients with major depressive disorder. A systematic review, BMC Psychiatry (2017)17:58.)

Another broad class of agents for treatment of mental health disorders is monoamine (MAOI’s) targeted products which induce the release of monoamine neurotransmitters (e.g., dopamine, serotonin, or epinephrine) from neurons. Monoamine releasers rapidly modulate the brain systems that are more gradually affected by SSRIs. MAOI’s act as a stimulant and euphoric effects that can lead them to have high abuse liability. For example, although psychostimulants in this class were widely employed in the mid-20th century to treat affective disorders, obsessive-compulsive disorders, and schizophrenia, use of such agents (e.g., amphetamines) is now primarily limited to treating attention deficit hyperactivity disorder (ADHD), and even this use is increasingly restricted.

Various FDA-approved drugs are also prescribed to treat symptoms of mental health disorders “off label” (i.e., for unapproved indications).

A last resort for patients with serious or refractory (i.e., treatment resistant) conditions is employment of direct brain interventions. For instance, one option when other treatments are unsuccessful is electroconvulsive therapy (ECT). ECT is a procedure done under general anesthesia in which electric currents are passed through the brain, intentionally triggering a brief seizure. Various surgical procedures also have been developed. These primarily involve targeted ablative procedures, i.e., causing the irreversible destruction of specific brain tissue. Others involve the implantation of devices directly into the brain, one example being “deep brain stimulation,” where electrodes are inserted into a specific brain region to generate electrical pulses.

In human clinical studies currently underway, evidence has started to accumulate demonstrating that certain agents in the phenethylamine and tryptamine classes that engage serotonin receptors directly show promise of rapid and long-lasting therapeutic effects in treating mental health disorders following only limited doses. For instance, studies using the Schedule I controlled drugs 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin (the active ingredient in “magic” mushrooms) have shown promise in rapidly and effectively treating mental health disorders such as chronic alcohol dependence, treatment-resistant depression, and PTSD, when taken in combination with psychotherapy. (Canal C. E. (2018). Serotonergic Psychedelics: Experimental Approaches for Assessing Mechanisms of Action. Handbook of experimental pharmacology, 252, 227–260.)

Accordingly, there is clear need for novel compositions to effectively treat patients who do not respond to current interventions, especially without the numerous drawbacks of those inventions. Such novel compositions would be highly sought after both to relieve the suffering of individual patients as well as to reduce the societal burdens created by untreated and undertreated mental health disorders.

Clinical Research with Psilocybin

In the early 1960s, psilocybin became available to academics for research. At Harvard University, Timothy Leary and his associates Ralph Metzner and Richard Alpert (later Ram Dass) performed research using synthesized psilocybin obtained from Hofmann’s lab at Sandoz. Some studies, such as the Concord Prison Experiment, suggested promising results using psilocybin in clinical psychiatry. However, because of concerns about the increase in unauthorized use of psychedelic drugs by the general public, psilocybin became federally illegal in 1970, added to Schedule I of the Controlled Substances Act—the most restrictive class of drugs reserved for substances that “have no currently accepted medical use,” “a lack of accepted safety for use under medical supervision, and a high potential for abuse.” These restrictions on its use made funding for academic research on psilocybin difficult to obtain, and scientists working with it terminated their research or became increasingly marginalized.

After several decades in the shadows, psychedelic drugs and their effects have again became the subject of scientific study, starting in the 1990s and increasing to the present. The return of interest in psychedelics, and the advances in neuropharmacology, neuropsychology, and brain imaging techniques that have opened new research paths, have refocused attention on psilocybin as part of what has been called “the psychedelic renaissance.” (Carhart-Harris, R. L.; Goodwin, G. M. (2017) The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future, Neuropsychopharmacol., 42, 2105-13.)

A recent major study with psilocybin was performed by researchers at UCLA with patients suffering from anxiety related to terminal cancer. Patients were given psilocybin or placebo. Psilocybin was found to significantly reduce anxiety and depression scores, and that these reductions were maintained over the course of six months (Grob et al. (2011) Pilot Study of Psilocybin Treatment for Anxiety in Patients with Advanced-Stage Cancer. Arch Gen Psychiatry, 68(1), 71-78).

In a later study at NYU School of Medicine, psilocybin and placebo were also compared in 29 patients with terminal cancer, and treatment was also accompanied by several sessions of psychotherapy. Psilocybin was found to greatly improve anxiety and depression scores. At the six-month follow-up, around 80% of the patients still had clinically significant reductions in depression (Ross et al. (2016) Rapid and Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety and Depression in Patients with Life-Threatening Cancer: A Randomized Controlled Trial. J. Psychopharmacol., 30(12), 1165-80).

A team at Johns Hopkins University has carried out a similar study on 51 terminal patients, giving patients psilocybin in the presence of trained facilitators. This study also found significant decreases in anxiety and depression scores, and reported around 80% of participants still had clinically significant improvements after six months (Griffiths et al. (2016) Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients With Life-Threatening Cancer: A Randomized Double-Blind Trial. J. Psychopharmacol., 30(12), 1181-97).

At the time of this filing, over a dozen research studies with psilocybin have recently completed, and over a dozen more are currently in progress. Such studies have examined or are examining the effects of psilocybin in the treatment of obsessive-compulsive disorder (OCD), major depressive disorder (MDD), depression and anxiety in life-threatening cancer, alcohol and nicotine dependence, and other diseases and mental health disorders.

Allied intends that through its medical research an additional treatment option may be able to be offered to the patients who need it.

For more information on Allied Corp., visit www.allied.health

About Allied Corp.
Allied Corp. is an international medical cannabis production company with a mission to address today’s medical issues with targeted psilocybin and cannabinoid health solutions. Allied Corp. uses an evidence-informed scientific approach to make this mission possible, through cutting-edge pharmaceutical research and development, innovative plant-based production and unique development of therapeutic products.

Investor Relations:
ir@allied.health
1-877-255-4337

Forward-Looking Statements:

This press release contains “forward-looking information” within the meaning of applicable securities laws in Canada or “forward-looking statements” made pursuant to the “safe harbour” provisions of the United States Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking information may relate to the Company’s future outlook and anticipated events, plans or results, and may include information regarding the Company’s objectives, goals, strategies, future revenue or performance and capital expenditures, and other information that is not historical information. Forward-looking information can often be identified by the use of terminology such as “believe,” “anticipate,” “plan,” “expect,” “pending,” “in process,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “can,” the negatives thereof, variations thereon and similar expressions. The forward-looking information contained in this press release is based on the Company’s opinions, estimates and assumptions in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward looking statements in this press release include the following: that Allied is leveraging the conditions in its Colombia grow operation and future Kelowna location to support its Research and Development efforts; that Allied is making important strides forward to position itself as a leader in the medical cannabis space, that Allied intends to make a series of proposed trademark and other intellectual property protection filings, as part of the Company’s Intellectual Property and Pharma Development (IP&PD) Strategy, statements respecting the joint development, manufacturing, and introduction of TACTICAL RELIEF™ branded products, and the use of proceeds from the offering of convertible notes.

There can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Risk factors that could cause actual results to differ materially from forward-looking information in this release include: the Company’s exposure to legal and regulatory risk; the effect of the legalization of adult-use cannabis in Canada and Colombia on the medical cannabis industry is unknown and may significantly and negatively affect the Company’s medical cannabis business; that the medical benefits, viability, safety, efficacy, dosing and social acceptance of cannabis are not as currently expected; that adverse changes or developments affecting the Company’s main or planned facilities may have an adverse effect on the Company; that the medical cannabis industry and market may not continue to exist or develop as anticipated or the Company may not be able to succeed in this market; risks related to completion of the greenhouse construction in Colombia, risks related to market competition; risks related to the proposed adult-use cannabis industry and market in Canada and Colombia including the Company’s ability to enter into or compete in such markets; that the Company has a limited operating history and a history of net losses and that it may not achieve or maintain profitability in the future; risks related to the Company’s current or proposed international operations; risks related to future third party strategic alliances or the expansion of currently existing relationships with third parties; that the Company may not be able to successfully identify and execute future acquisitions or dispositions or successfully manage the impacts of such transactions on its operations; risks inherent to the operation of an agricultural business; that the Company may be unable to attract, develop and retain key personnel; risks resulting from significant interruptions to the Company’s access to certain key inputs such as raw materials, electricity, water and other utilities; that the Company may be unable to transport its cannabis products to patients in a safe and efficient manner; risks related to recalls of the Company’s cannabis products or product liability or regulatory claims or actions involving the Company’s cannabis products; risks related to the Company’s reliance on pharmaceutical distributors; that the Company, or the cannabis industry more generally, may receive unfavourable publicity or become subject to negative consumer or investor perception; that certain events or developments in the cannabis industry more generally may impact the Company’s reputation or its relationships with customers or suppliers; that the Company may not be able to obtain adequate insurance coverage in respect of the risks that it faces, that the premiums for such insurance may not continue to be commercially justifiable or that there may be coverage limitations and other exclusions which may result in such insurance not being sufficient; that the Company may become subject to liability arising from fraudulent or illegal activity by its employees, contractors, consultants and others; that the Company may experience breaches of security at its facilities or losses as a result of the theft of its products; risks related to the Company’s information technology systems; that the Company may be unable to sustain its revenue growth and development; that the Company may be unable to expand its operations quickly enough to meet demand or manage its operations beyond their current scale; that the Company may be unable to secure adequate or reliable sources of necessary funding; risks related to, or associated with, the Company’s exposure to reporting requirements; risks related to conflicts of interest; risks related to fluctuations in foreign currency exchange rates; risks related to the Company’s potential exposure to greater-than-anticipated tax liabilities; risks related to the protection and enforcement of the Company’s intellectual property rights, or the intellectual property that it licenses from others; that the Company may become subject to allegations that it or its licensors are in violation of the intellectual property rights of third parties; that the Company may not realize the full benefit of the clinical trials or studies that it participates in; that the Company may not realize the full benefit of its licenses if the licensed material has less market appeal than expected and the licenses may not be profitable; as well as any other risks that may be further described in and the risk factors discussed in the Company's continuous disclosure including its Management's Discussion and Analysis sections in its Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and Current Reports on Form 8-K filed under the Company's profile at www.sec.gov.

Although management has attempted to identify important risk factors that could cause actual results to differ materially from those contained in the forward-looking information in this presentation, there may be other risk factors not presently known to the Company or that the Company presently believes are not material that could also cause actual results or future events to differ materially from those expressed in such forward-looking information in this presentation. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers and viewers should not place undue reliance on forward-looking information, which speaks only as of the date made. The forward-looking information contained in this release represents the Company’s expectations as of the date of this release or the date indicated, regardless of the time of delivery of the presentation. The Company disclaims any intention, obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required under applicable securities laws.