Alzheimers Archives - Green Market Report

StaffJune 23, 2022
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4min5470

India Globalization Capital, Inc. (IGC) (NYSE: IGC) announces its financial results for the fiscal year ending March 31, 2022. IGC reported that its revenue was approximately $397 thousand and $898 thousand for Fiscal 2022 and Fiscal 2021, respectively. The net loss for Fiscal 2022 for IGC was approximately $15 million or $0.30 per share, compared to approximately $8.8 million or $0.21 per share for Fiscal 2021. Adjusting for approximately $5.3 million in one-time and non-cash expenses, the net loss is approximately $9.7 million in Fiscal 2022.

In Fiscal 2022 and Fiscal 2021, revenue was primarily derived from the Life Sciences segment, which involved sales of in-house brands and alcohol-based hand sanitizers, among others. In Fiscal 2022, the company de-emphasized the manufacturing and sale of low-margin hand sanitizers and shifted its focus to higher-margin white label services and the sale of products under its brands. This increased the gross margin from 12% in Fiscal 2021 to 48% in Fiscal 2022. The infrastructure segment had lower revenue in Fiscal 2022 due to the continued impact of the COVID-19 pandemic.

The company has roughly $10 million in cash on hand. SG&A expenses increased by approximately $5.3 million or 68% to $13.2 million for Fiscal 2022, from approximately $7.9 million for Fiscal 2021. The increase is attributed to one-time expenses, which include law-suit settlement expenses of approximately $264 thousand; impairment of facility of $833 thousand; net realizable value (NRV) adjustment of $1.7 million for its hemp crop; approximately $475 thousand in provisions for advances paid; approximately $1.7 million in provisions against inventory that was stolen at our vendor’s facility; and an increase of approximately $1.3 million attributable to non-cash expenses. Adjusting for approximately $5.3 million in one-time and non-cash expenses, the SG&A for the fiscal year 2022 was lower year over year by approximately $500 thousand.

R&D

Research and Development expenses were attributed to the Life Sciences segment. The R&D expenses increased by approximately $1.4 million or 151% to $2.3 million in Fiscal 2022, from approximately $929 thousand for Fiscal 2021. The increase is attributed to the now completed Phase 1 clinical trial on Alzheimer’s. “We expect R&D expenses to increase with progression in Phase 2 trials on IGC-AD1 and pre-clinical trials on TGR-63.”

Alzheimer’s

IGC completed the first-in-human safety and tolerability trial on its tetrahydrocannabinol (THC) based investigational new drug IGC-AD1. During the trial, the company discovered positive signals for improving several neuropsychiatric symptoms including agitation in dementia associated with Alzheimer’s. “Based on these signals, we are initiating a larger efficacy trial to test IGC-AD1 as a symptom modifying agent, specifically on agitation in dementia due to Alzheimer’s disease.”

On June 7, 2022, the USPTO issued a patent (#11,351,152) to IGC titled “Method and Composition for Treating Seizures Disorders.” The patent relates to compositions and methods for treating multiple types of seizure disorders and epilepsy in humans and animals using a combination of cannabidiol (CBD) with other compounds. Subject to further research and study, the combination is intended to reduce side effects caused by hydantoin anticonvulsant drugs such as phenobarbital, by reducing the dosing of anticonvulsant drugs in humans, dogs, and cats.


Dave HodesJune 3, 2022
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14min11730

The conditions that psychedelics can treat have doubled in the last few years to include migraine headaches, Parkinson’s disease, autism, alcoholism, drug addiction, gambling addiction, and more. 

But one of the more intriguing conditions that researchers are looking at is Alzheimer’s disease, a disease that has evaded the best efforts of treatment by medical science since it was first discovered in 1906, named after German physician Dr. Alois Alzheimer. 

The disease affects 6.2 million Americans; global cases are forecast to be over 150 million by 2050, nearly triple the number in 2019.

Finding treatment for Alzheimer’s has been the focus of growing government assistance for years, most recently when a $350 million increase for Alzheimer’s and dementia research funding at the National Institutes of Health (NIH) was signed into law in 2019, bringing the annual funding to $2.8 billion. 

Slow Alzheimer’s Progress

But progress toward a treatment has been slow going.

For example, on June 7, 2021, U.S. Food and Drug Administration (FDA) approved aduhelm (aducanumab) for the treatment of Alzheimer’s using the accelerated approval pathway, which can be used to advance research for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. 

Aduhelm offered a brief glimmer of hope with claims that it could actually slow the progression of the disease. But after backlash from the medical community (in part because of a common side effect of swelling in areas of the brain, with small spots of bleeding), restrictions on its use by Medicare, and questions about the FDA’s approval process, the pharmaceutical company that makes aduhelm, Biogen (NASDAQ:BIIB), essentially dropped it in May, 2022. (Biogen is reportedly working on another formulation for treating Alzheimer’s). 

That failure to bring to market the first approved Alzheimer’s drug in 20 years by a well-capitalized biotech company that posted $11 billion in revenue in 2021 has served to incite more activity in alternative therapies—such as psychedelics—to save the day and change the Alzheimer’s treatment narrative going forward. 

In fact, the psychedelics industry has been flirting with finding a successful treatment for Alzheimer’s since 2015, years before Biogen took their shot at a drug, when Eleusis, a life science company based in London and New York, conducted two clinical trials of lysergic acid diethylamide (LSD) focused on establishing a basic framework for the future clinical development of psychedelics in the context of Alzheimer’s disease and depression.

On the surface of the issue, Big Pharma appears to have the upper hand for now. In 2020, there were 121 therapies in clinical trials for Alzheimer’s disease.

And there is a handful of big mainstream biotechnology companies still pursuing Alzheimer’s drug development—including Cassava Sciences (NASDAQ: SAVA), moving forward with their phase 3 studies of Alzheimer’s; Annovis Bio (NYSE: ANVS), announcing in May positive feedback from the FDA for two phase 3 clinical trials with their Alzheimer’s and Parkinson’s drug, buntanetap; and Alector Therapeutics (NASDAQ:ALEC), with three Alzheimer’s programs in the pipeline—two in partnerships with one of the largest pharmaceutical companies, Abbvie, which has $50 billion invested in overall research and development for various classes of pharmaceuticals.

Other biotech businesses pursing Alzheimer’s treatment are Biohaven Pharmaceuticals, AZ Therapies, VTV Therapeutics, AgeneBio and others, all showing little or no success so far, effectively causing biotech businesses to put Alzheimer’s work on the back burner.

The World Health Organization registry shows that there were 170 drugs in development for Alzheimer’s worldwide in 2020, contrasting with 433 for diabetes. Pfizer reportedly completely abandoned Alzheimer’s research in 2018 and laid off 300 employees. It’s this sort of disparity that reflects biotech’s problems: limited availability of biomarkers, longer trial durations, greater expense, and higher risk of failure of Alzheimer’s drug development programs, according to a study published by the Alzheimer’s Association.

Psychedelics Tackle Alzheimers

Psychedelic companies are sensing an advantage now to come up with an Alzheimer’s treatment that stands up to the challenges of both FDA scrutiny and patient benefit. Treatment for this disease is right in its wheelhouse. 

Studies with psilocybin and LSD, coupled with anecdotal reports of cognitive benefits from micro-dosing, suggests that psychedelics may have a therapeutic role in a range of psychiatric and neurological conditions due to their potential to stimulate neurogenesis, provoke neuroplastic changes and reduce neuroinflammation—what mainstream pharma has been attempting to do with their newer chemical concoctions to treat Alzheimer’s over the last five years. Psychedelics also induce brain plasticity and modify connectivity between brain regions which is thought to help patients with Alzheimer’s. 

In fact, all known genetic and environmental risk factors for Alzheimer’s are associated with increased inflammation, suggesting that reducing inflammation could be a target for preventing Alzheimer’s. Psychedelics have been shown to have potent anti-inflammatory properties and may represent a unique anti-inflammatory overwhelmingly targeted to brain tissue. “This inevitably makes them (psilocybin and LSD) interesting candidates for therapeutics in dementia,” a study concluded.

So it seems that biotech businesses have tried and failed to find a treatment for Alzheimer’s, and it’s time for psychedelics to take their shot.

In December, 2021, Mynd Life Sciences (CSE: MYND) (OTC: MYNDF) acquired Cava Healthcare Inc., a life sciences company based in Surrey, British Columbia, which included all future worldwide rights relating to the use of psychedelics to treat Alzheimer’s disease and other dementias.

And right now, there are three psychedelics clinical trials running or recruiting participants for studying the effect of psychedelics on Alzheimer’s, including one sponsored by Johns Hopkins University using psilocybin to see if it’s safe and effective for depression in people with mild cognitive impairment (MCI) or early Alzheimer’s disease. 

The study will also assess whether psilocybin may improve an Alzheimer’s patient’s quality of life. The study began in March, 2021 with results expected in late December, 2023.

Other psychedelics companies in the race for an Alzheimer’s treatment include Ixtlan Bioscience, based in Tel Aviv, which recently announced a new patent for psilocybin treatment of Alzheimer’s.

For now, it’s a sort of standoff: take one of the usual six medications for treating the symptoms of Alzheimer’s and suffer through side effects of nausea, increased bowl movement, vomiting and loss of appetite. Or accelerate the trials and spread out the funding to more psychedelics companies to finally arrive at a psychedelics-assisted therapy that treats the symptoms without a list of grim side effects—going far beyond anything that mainstream medicine has available now for Alzheimer’s. 

Could psilocybin, or LSD, or some new related psychedelic formulation yet to be discovered stop the progress of this terrible neurological disorder? Could they even reverse it altogether? For the first time in a long time, that possibility is not as improbable as it used to be.


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