The company's debts totaled C$136.5 million by the end of 2022.
The company's debts totaled C$136.5 million by the end of 2022.
Costs of the therapy are estimated at up to $15,000.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) is submitting a clinical trial application (CTA) for a Phase I combinatorial study that will document the safety of Optimi’s natural psilocybin standardized extract and proprietary 3,4-methylenedioxy-
The single site, double-blind, five arm study will include 25 participants randomized into one of five groups to undergo a supervised experimental session. Participants will receive either 25mg of natural psilocybin and a placebo, 125mg of MDMA and a placebo, or 25mg of natural psilocybin in combination with MDMA (50mg, 80mg, or 125mg).
“With an estimated 25,000 to 100,000 therapists needed to support the millions of people suffering with post-traumatic stress disorders, Optimi feels strongly that clinical research undertaken at this stage by GMP cultivators and formulators in partnership with mental health training services such as ATMA should be geared toward meeting this immediate need,” said CEO Bill Ciprick. “Therapists provided experiential training with both substances will in turn be able to provide greater value and higher standards of care to patients undergoing these treatments.”
Earlier this week, Optimi announced the successful completion of its novel MDMA drug candidate, OPTI-MHCL, which was tested for purity on-site with a result of >99% over multiple consistent batches by Chief Science Officer, Justin Kirkland. Both drug candidates are scheduled to be administered in the clinical trial and will be manufactured in-house at Optimi’s 20,000-square-foot facilities in Princeton, British Columbia. The company believes that the work it did in 2022 will have an impact this year.
The company said in a statement that the investigator-initiated double-blind placebo-controlled study is being conducted through ATMA Journey Centers in Calgary, Alberta, and will be the first of its kind to directly compare the acute effects of these substances within the same clinical study. ATMA is currently the only Canadian organization that has completed a successful Phase I safety trial with natural psilocybin in healthy therapists.
Optimi said that the primary objective of the trial is to demonstrate the safety and tolerability of the combinatory use of natural psilocybin and MDMA in healthy participants, broadly validating its offering and, in later stages, indicating the suitability for use of these substances, combined and separately, in experiential training by psychedelic therapy practitioners.
“This is about helping people heal. Optimi Health receives emails from patients and physicians on an almost daily basis, searching for our help in obtaining some level of mental health support and asking when these modalities might be available to them,” said Ciprick. “They are entrusting us to deliver because they still have hope, and that is why we have set an ambitious course of action in 2023 that will help therapists complete their training in time to bring them the support they need. This trial offers a tangible step forward in that essential process, for which the endpoint is providing relief for countless sufferers.”
MDMA and psilocybin used for therapy will be reclassified by July 1, 2023.
PharmaAla to supply the MDMA.
Can psychedelics really treat the wide range of conditions being considered?
Researchers looking more closely at similarities of compounds and responses.
Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) posted positive results as revenue rose along with patients — showing the growing demand for psychedelics-centered therapy to treat addictions. The Canadian biotechnology company released its financial report card for the second quarter ending July 31.
Awakn posted revenues of C$339,872 via Awakn’s clinics for the second quarter, versus no revenue in the prior year. The second quarter revenue is up C$86,718, or 34% over the quarter.
The company said that revenue “during the seasonally quietest period of the year for our services” was primarily driven by the provision of ketamine-assisted therapies at the London, Bristol and Oslo Awakn clinics. These clinics were not open during the equivalent period last year.
“Today’s results and revenue growth demonstrate the continued momentum building in our business and the successful execution of our business plan in both pillars of the business: R&D and Commercialization,” CEO Anthony Tennyson said.
Over the quarter, Awakn received approval for its Phase III clinical trial for ketamine-assisted therapy for the treatment of Alcohol Use Disorder. This is the first time a government agency has funded a Phase III trial in psychedelics.
The company received C$2.5 million from U.K.’s National Institute for Heal and Care Research to cover 66% of the costs of the trial. The company will bankroll the rest.
“We have also made excellent progress in strengthening the IP moats for our ketamine and MDMA programs,” Tennyson said, referring to the competitive advantage of its intellectual property.
The company had C$481,830 in cash. It also announced the closing of a private placement – issued 1,880,454 units at a price of C$0.55 per unit raising gross proceeds of C$1,034,250.
“We have also successfully launched our licensing partnership business into the U.S. and Canada, putting us in the unique position of being a biotech with commercial operations in four territories, the U.K., the U.S., Canada and Norway, in only our second full financial year,” Tennyson said
Through the rest of the fiscal year, Awakn said it anticipates receiving regulatory and ethics approval for its Phase III clinical trial for ketamine-assisted therapy, as well as completing its behavioral study of ketamine in gambling addiction.
The company will also look to further its therapeutics commercialization through acquiring more licensing partners utilizing the company’s intellectual property moat ketamine-assisted therapy for treatment of Alcohol Use Disorder in the U.S. and Canada.
MDMA, or methylenedioxymethamphetamine, has become more of a psychedelics wonder drug today, distancing itself as the rave party fuel (ecstasy or Molly) that it was in the 1980s and being positioned as the wonder drug that psychedelics researchers have hoped for.
Researchers have discovered that MDMA, with structural similarities to both mescaline and methamphetamine, can help with post traumatic stress disorder. MDMA can also help with autism. Anorexia nervosa. Social anxiety. Drug addiction. Alcoholism. Diabetes. Chronic pain. Fibromyalgia. Rheumatoid arthritis. Parkinson’s disease. Even hangovers.
There are 69 MDMA studies either completed or ready to begin in the U.S., Switzerland, Spain, the Netherlands, Canada, the UK, Germany, and Israel. Nearly half are for PTSD.
All this encouraging treatment news comes from a substance patented over 100 years ago by the pharmaceutical giant Merck in 1914. MDMA was found to have an onset of 30-45 minutes, and create a two to four hour experience characterized by euphoria, increased well-being, sociability, self-confidence, and extroversion.
Psychiatrists used MDMA briefly in the 1970s and 1980s before it ended up as a party drug.
As a result of the use of MDMA being overused in raves and causing deaths and injuries, the Drug Enforcement Administration (DEA) declared an emergency ban in 1985 and listed it as a Schedule 1 drug.
But that did little to slow down the progress of its development. In the early 1990s, the FDA approved the first human trial exploring whether MDMA could help relieve pain in terminally ill patients, as well as serve as an adjunct to psychotherapy.
Then MDMA began inching its way up the list of substances to study with psychedelics researchers when, in 1998, research with humans began in earnest at the UCLA Medical Center. More interest was generated in 2011, with the results of the first randomized controlled pilot study into MDMA for PTSD.
In 2017, the FDA granted breakthrough therapy designation for MDMA to the Multidisciplinary Association for Psychedelic Studies (MAPS), an organization intent on driving further development.
In 2020, a MAPS phase 3 clinical MDMA trial was successful, and a second phase 3 trial is currently underway supported by $30 million in funding. “It’s only now in 2020 that we have been able to generate evidence supporting safety and efficacy in the context of an FDA-regulated Phase 3 clinical trial,” Rick Doblin, founder and executive director of MAPS, wrote in a MAPS bulletin after the first clinical trial. “Our current timetable for the potential of FDA approval is the first half of 2023, 37 years after the DEA kept both the therapeutic and social use of MDMA illegal.”
MAPS has also developed the first validated commercial synthetic process for producing multi-kilogram batches of MDMA under current Good Manufacturing Practices, making larger quantities of MDMA available to help with ongoing clinical trials and provide for future therapeutic use.
MDMA’s moment in the limelight will continue growing, as the need for any help with PTSD expands nearly daily. The MAPS clinical trial researchers noted that the timing is right for MDMA. “We may soon be confronted with the potentially enormous economic and social repercussions of PTSD, exacerbated by the COVID-19 pandemic. Overwhelmingly high rates of psychological and mental health impairment could be with us for years to come and are likely to impart a considerable emotional and economic burden. Novel PTSD therapeutics are desperately needed, especially for those for whom comorbidities confer treatment resistance.
“Not only is MDMA-assisted therapy efficacious in individuals with severe PTSD, but it may also provide improved patient safety. Compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to dramatically transform treatment for PTSD and should be expeditiously evaluated for clinical use.”
Public funding for new mental health discoveries that can change the lives of millions of Americans for good? In a word: Absolutely.
Over the last three years, clinical trials of psilocybin and MDMA psychedelics assisted therapy in particular have demonstrated their value in treating various mental health conditions, even hard to treat conditions such as so-called treatment resistant depression. It is believed that this new therapy offers real hope for the hopeless.
The clinical trials excitement is tempered by the fact that there are still many answers needed about how various psychedelic substances work inside the human brain. There is so much more work to do. But that is precisely why more public funding is needed.
To be sure, hundreds of millions of dollars in philanthropic investment are actively making a difference. One example: Stephen Jurvetson, co-founder of Future Ventures and a board member at SpaceX, is reportedly giving about half of his net worth to fund psychedelic science.
The Psychedelic Science Funders Collaborative (PSFC), a nonprofit organization founded in 2017 created to support scientists and organizations working on psychedelic clinical trials, includes some of the leading funders of psychedelic medicine who are supporting organizations at the cutting edge of psychedelic research. PSFC has funded several organizations at the forefront of the psychedelic field, and, in 2020, completed a $30 million fundraising campaign in partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to support the completion of phase 3 clinical trials of MDMA-assisted psychotherapy.
PSFC’s current areas of focus includes supporting broad and equitable access to high-quality MDMA-assisted psychotherapy post-FDA approval, and supporting the implementation of Oregon’s Measure 109.
It seems that almost every week, another business leader or philanthropist steps up with a psychedelics funding objective—SpaceX founder Elon Musk, Groupon co-founder Andrew Mason, even an anonymous Bitcoin millionaire. But it’s not enough. Deeper pockets are needed for more historic and life-changing outcomes that psychedelics research has just begun to deliver.
A primary source of federal medical science funding comes from the National Institutes of Health (NIH). NIH-funded research has contributed to a 60 percent reduction in the death rates for coronary heart disease and stroke, a 40 percent decline in infant mortality over the past 20 years, and a 30 percent decrease in chronic disability among seniors.
Psychedelics research is at a point where it is ripe for more government funding, as a growing number of U.S. cities and states are taking legislative action to decriminalize or legalize psychedelic use and/or research; and a new Harris Poll reporting that nearly two thirds of Americans who suffer from anxiety/depression/PTSD believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD.
And then: The DEA stepped up its allowable production quotas for psychedelics in November citing “a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes.”
There has been a glimmer of hope for public funding in psychedelics. In October, Johns Hopkins Medicine was awarded a grant from the NIH to explore the potential impacts of psilocybin on tobacco addiction. This is the first NIH grant awarded in over a half century to directly investigate the therapeutic effects of a classic psychedelic.
With that announcement comes reference to the stigma problem that began when studies on LSD and other psychedelics that were raging over 50 years ago, in the 1960s and 1970s. LSD became a victim of a politized youth culture at the time that turned the potential therapeutic good of LSD into just another party drug problem. It was made illegal by the DEA as a Schedule 1 drug. Recovering from over 50 years of public disparity has been achieved somewhat, but it is still an ongoing issue with not just LSD but all psychedelics.
It’s clear that today, the NIH needs to get into the psychedelics game in an even bigger way than just its recent grant to Johns Hopkins. The limited support from philanthropic sources has funded the research so far, but these are restricted trials of relatively small samples of patients because of the cost of doing larger studies.
By contrast, NIH is the largest single public funder of biomedical research in the world. Every state and almost every Congressional district has earned a share of this investment. NIH investments in research focused on a particular area has been found to stimulate increased private investment in the same area. A $1.00 increase in public basic research stimulates an additional $8.38 of industry R&D investment after 8 years. A $1.00 increase in public clinical research stimulates an additional $2.35 of industry R&D investment after 3 years.
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