MindBio Therapeutics Corp. said that “MB22001, a proprietary and self-titratable form of Lysergic Acid Diethylamide (LSD) designed for safe take home microdosing” has been approved for take-home use in a pair of clinical trials.

“The trials in women’s health aim to address a huge unmet need in effectively treating Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric disorder (PMDD) without the side effects of anti-depressants and the combined oral contraceptive pill often used in treatment,” the company said in a press release.

The company “now has in its portfolio, multiple Phase 2B clinical trials underway and in a series of world firsts,” the press release said.

“This month, MindBio aims to present secondary data relating to its recently completed Phase 2A trial of MB22001 in patients with Major Depressive Disorder. The Company has already met its primary end-point using the global standard Montgomery-Asberg Depression Rating Scale (MADRS) to show a 60% drop in depressive symptoms and 53% complete remission from depression by week 8 of treatment,” the company said in the release. 

“The secondary data presentation will report on post treatment effects, using the MADRS and several other vital clinical scales for measuring the effects of MB22001 on each clinical trial participant’s mental health. The readouts are important to understanding the full impact on patients of this novel medicine and if the results continue to be positive, strengthening the position of this drug as it progresses towards Phase 3 clinical trials.”

As Benzinga explains, MindBio’s thesis “is that it can be used acutely during specific periods of the menstrual cycle, with targeted dosing to treat negative mood symptoms.” 

“This thesis is based on three main facts a) The acute dose day mood-elevating effects of MB22001 have been demonstrated in MindBio’s Phase 1 trials b) MindBio’s Phase 2a open-label trial in depressed patients show long-term improvements in mood and c) reports in the grey literature of people self-medicating for PMS/PMDD using LSD microdoses,” Benzinga said. “Premenstrual syndrome (PMS) is estimated to affect ~25% of all women who menstruate – equivalent to 956 million women worldwide. A particularly severe form of PMS is termed premenstrual dysphoric disorder (PMDD) which affects 3-8% of women who menstruate. Current treatments for these issues are selective serotonin reuptake inhibitors (SSRIs), given either continuously or daily during the luteal phase of the menstrual cycle. While SSRIs can be effective for some with PMDD approximately 40% of women with PMDD do not respond to SSRIs, and common side effects of SSRIs when used for PMDD include nausea, decreased energy, somnolence, fatigue, decreased libido and sweating.”

MindBio bills itself as a “pioneering clinical studies into the microdosing of psychedelic medicines to treat a range of medical conditions such as depression, anxiety, PTSD, panic disorder, chronic pain and opiate addictions,” and that invests in “clinical research to discover potential new treatment options and we aim to create novel medicines and treatment regimes from breakthrough microdosing studies.”

The company provides more background on this year’s clinical trials of MB22001.

“Phase 2a clinical trials completed in March 2024 using MB22001 in Major Depressive Disorder.  The Phase 2a clinical trial resulted in 53% of depressed patients entering the trial being in complete remission after 8 weeks of treatment. Overall, there was a 14.1 drop in MADRS Score (Montgomery-Asberg Depression Rating Scale). The MADRS is a global standard for measuring the severity of Clinical Depression. Overall there was an impressive 60% drop in Depressive symptoms at week 8 of the trial,” the company explains, adding that it has “just started dosing in a Phase 2b depression trial.”  

“In this randomised active placebo-controlled trial, 90 patients with Major Depressive Disorder will be given microdoses of MB22001 or an active placebo over an 8 week period.  At the end of the 8 weeks, all participants in the placebo and drug group will be offered an 8 week extension to ensure the placebo group has the opportunity to trial MB22001,” it continues. “A second Phase 2b trial in late stage cancer patients is also currently underway.  This cancer study will evaluate the feasibility of conducting a randomised controlled trial comparing psychedelic-microdose assisted Meaning-Centred Psychotherapy to standard Meaning-Centred Psychotherapy in people who have advanced cancer and anxiety or depression.”

Participants in the trials “will be randomised to receive psychotherapy alongside doses of either an LSD microdose or placebo,” MindBio said. 

“The feasibility, acceptability, safety and potential psychological benefits of this intervention will be assessed. Our findings will inform the development of a larger trial and provide an initial indication of the potential benefits of psychedelic microdosing in advanced cancer.”

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A pharmaceutical company unveiled an experimental new drug that is being touted as a less dangerous alternative to opioids. To date, few drugs have demonstrated enough power to manage higher levels of pain often associated with post-surgery recovery.

WXYZ Detroit, an ABC affiliate, reports that Vertex Pharmaceuticals said Tuesday the drug’s use in late-stage clinical trials resulted in “clinically meaningful reduction in pain,” without many of the risks associated with opioids. The new drug is called VX-548 and it’s showing promise in early stages.

Two trials demonstrated that patients who recently came out of surgery who received Vertex’s new drug had statistically significant pain relief. Phase 2 trial results were published Dec. 13, 2023, noting its effects on painful diabetic peripheral neuropathy. Researchers in a third trial observed a wider range of pain-related conditions. Phase 3 trial results were published on Jan. 30, 2024 and showed “clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials,” as well as many other surgery-related conditions. 

Participants who used the drug for up to 14 days also noted positive results, with over 83% of patients saying VX-548 was “good” to “excellent” at managing pain.  

Vertex noted VX-548 was “safe and well-tolerated in all three studies,” but it failed to work better than hydrocodone bitartrate/acetaminophen, aka Vicodin. The National Library of Medicine notes that pain is a complex phenomenon, and that one type of painkiller won’t work for all situations.

Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by mid-2024 regarding VX-548’s treatment of moderate-to-severe acute pain. Vertex’s Phase 1-3 trials move the company closer to gaining approvals from the FDA. If they are successful, it could  provide people in the U.S. with another pain treatment option.

Opioids Main Driver of U.S. Drug Overdoses

The vast majority of drug overdoses in the U.S. continues to be dominated by opioids. And to make things worse, the confusion over addiction leads to making it harder for patients who actually need opioids to get them prescribed.

According to The National Center for Health Statistics (NCHS) under the U.S. Centers for Disease Control and Prevention, drug overdose deaths rose from 2019 to 2021 with over 106,000 drug overdose deaths reported in 2021. Deaths involving synthetic opioids—primarily fentanyl and excluding methadone—continued its death march with 70,601 overdose deaths reported in 2021. Fentanyl in particular kills 150 Americans per day.

Many other attempts to develop alternatives to opioids that effectively dull pain, but they typically fail. If Vertex’s drug is ultimately deemed to be safe, it could introduce a new class of acute pain medicine for the first time in about 20 years, Dr. Jessica Oswald told WXYZ.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options,” Oswald said. “The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management.”

Opioids kill more Americans than car crashes or gun violence. An alternative to effective, but highly dangerous opioids, some of which having the power to stop breathing, is sorely needed.

History of Opioid Alternatives

Bayer introduced heroin in 1898 and called it a “wonder drug” meant to be less addictive than morphine, which was ravaging America at the time with drug addicts. It wasn’t until over 10 years later that an army of heroin addicts emerged.

Cannabis itself has been explored as an opioid alternative, but it works in very different ways. One study is taking a closer look at the specific holistic effects that both medical cannabis and opioids provide to get more insight on the efficacy of each substance as it pertains to chronic pain management.

The recent study, “The holistic effects of medical cannabis compared to opioids on pain experience in Finnish patients with chronic pain,” was conducted by a team of researchers from Åbo Akademi University, who looked into the effects of medical cannabis and opioids for chronic pain treatment.

Published in the Journal of Cannabis Research, the study aimed to take a closer look at how effective medical cannabis is compared to traditional opioids in treating chronic pain, as cannabis use for symptom management has become increasingly more common in recent years. Results suggested that opioids and cannabis are both “equally efficacious” at mitigating pain intensity in patients with chronic pain, while cannabis offered more “holistic” relief in improving sleep, focus and emotional wellbeing.

Vertex Pharmaceuticals could help provide a safer alternative compared to typical opioids that have created an epidemic of drug overdoses in the U.S.

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Although the United Kingdom (U.K.) legalized medical cannabis in 2018, it has not approved any clinical studies and is not widely available as a prescription through the country’s National Health Services (NHS).

A recent report from Sky News provided an update on the NHS, stating that no studies have been funded to help explore the efficacy of medical cannabis yet. However, U.K.-based Celadon Pharmaceuticals recently began a clinical trial featuring 5,000 patients who suffer from chronic pain.

Earlier this year in March, Celadon Pharmaceuticals became the first company in the U.K. to be licensed by the British government, called the Home Office, to sell its products to private clinics that are legally allowed to prescribe cannabis.

At first Celadon Pharmaceuticals conducted a preliminary study, examining 500 patients and found that cannabis did help reduce patients’ reliance on opioids, and also helped improve sleep. This past summer, both the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS Research Ethics Committee approved of the larger Celadon clinical trial.

“As an approved Trial, it is believed to be the only one of its kind in the U.K., and is designed to create a data set that will support doctors’ prescriptions of cannabis-based medicines, and in time enable potential reimbursement by the NHS and insurance companies,” the company wrote in a press release this summer. “It also enables General Practitioners to prescribe the medicine to patients in addition to specialist doctors, and organisations such as charities can advertise recruitment for the Trial. The Company believes this to be a major advance in enabling much wider access for patients, ultimately leading to the opening up of the UK market for cannabis-based medicines.”

Celadon’s co-founder, James Short, more recently told Sky News that first and foremost, his business is a pharmaceutical company, not a cannabis company. “We’ve got to try and get away from the stigma. When I first got involved in the business I was nervous to even talk about it with friends,” Short said. “But our job is not to get people high. It’s to give them a better quality of life.”

Numerous patients, especially parents of young patients, have spoken out in favor of medical cannabis, and called the government to take action so that it could be more accessible and affordable for families. Hannah Deacon and her son Alfie Dingley, Emma Appleby and her daughter Teagan, Emma Matthews and her son Louis, Matt Hughes and his son Charlie, and Karen Gray and her son Murray from Scotland are just a few recognizable names of U.K.-based parents fighting for their kids’ rights to cannabis and an improved quality of life.

Families outside of the U.K. such as Irish mother Vera Twomey had called upon their own governments for improved treatment opportunities for her daughter, Ava, who suffered from Dravet syndrome. Sadly, Ava passed away earlier this year in May at age 13.

While there are many firsthand accounts of medical cannabis helping patients, U.K. doctors still remain hesitant. “In the aftermath of what happened with opioids the medical community is understandably a little bit skeptical about introducing a new drug without really robust evidence,” said NHS consultant and British Pain Society spokesperson, Dr. Alan Fayaz. “The opioid epidemic has perhaps done cannabis a bit of a disservice because it’s tainted ground.”

Furthermore, Fayaz said that the 2018 law change coming before clinical evidence was clear has been harmful to the cause. “It creates this bizarre two-tiered system which actually doesn’t advantage the patients on the NHS and it doesn’t really advantage the patients in the private sector either,” Fayaz explained. “I think what we need is the research to be able to identify the role cannabis will play.”

Currently only patients who manage a private prescription are able to gain access, which is incredibly expensive. Sky News spoke with Chad Martin, who pays £300 per month ($378 USD) to obtain medical cannabis to treat his arthritis. “I am fortunate to be able to afford the drug. Others can’t,” Martin explained. Initially his doctor prescribed opioids to treat his condition.

His cannabis medicine of choice is a cannabis inhaler, which helps treat pain and inflammation flare-ups. “When the weather changes, arthritis can affect you regardless, but cannabis has worked way better than anything else I’ve taken in the past,” Martin said.

The Home Office launched its cannabis review in June 2018. At the same time, the Home Secretary also announced that Alfie Dingley and Billy Caldwell would be granted a license to legally obtain cannabis to treat their conditions.
In 2019, the National Institute for Health and Care Excellence (NICE) decided that there wasn’t enough evidence that medical cannabis can help patients who suffer from epilepsy. Later in March 2021, NICE updated its 2019 stance on medical cannabis, clarifying that “There is no recommendation against the use of cannabis-based medicinal products.” Two years later in March 2023, NICE approved Epidyolex, a CBD-based medicine, for those who suffer from tuberous sclerosis complex.

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A biopharmaceutical company this week unveiled the results of a clinical trial it says showcases the potential of psychedelics as a mental health treatment.

The findings come via Cybin, a Canadian company “committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic treatment options.”

According to the company, the results centered around CYB003, Cybin’s “proprietary deuterated psilocybin analog” that showed “a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo.”

“At the 3-week primary efficacy endpoint, the reduction in major depressive disorder (“MDD”) symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points (p=0.0005, Cohen’s d=2.15). A p-value indicates statistical significance. Generally, values <0.05 are considered statistically significant and values <0.001 are considered highly statistically significant,” the company said in a press release on Tuesday.

Cybin’s Chief Medical Officer, Amir Inamdar, the chief medical officer at Cybin, said that the “interim results, together with emerging data from a number of academic studies, suggest that CYB003 may have therapeutic efficacy in range of mental health conditions.”

“Mental health disorders affect almost 1 billion people worldwide. Comorbid MDD occurs widely in medical and psychiatric disorders, including anxiety disorders and post-traumatic stress disorder, Inamdar. 

The company said that the phase 2 clinical trial is assessing the efficacy of the treatment based on the MADRS scale, or the “Montgomery-Asberg Depression Rating Scale” that is used to evaluate the level of depression in a patient.

According to Cybin, the trial showed a “a primary efficacy endpoint of reduction in depression symptoms (change from baseline in MADRS) at week 3 after a single administration.” 

“To date, dosing has been completed in all dose cohorts up to 16mg, with a favorable safety and tolerability profile and no treatment-related serious adverse events observed. Interim results from the 12mg dose cohort have demonstrated a statistically significant and clinically meaningful reduction in symptoms of depression with a single dose at three weeks after treatment,” the company said in the press release.

“The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD. It is widely used in clinical trials and accepted by regulatory authorities worldwide as a measure of symptoms of depression. The MADRS includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0 to 6 giving a total score ranging from 0 to 60. Typical score ranges for severity are: 0-6 normal; 7-19 mild; 20-34 moderate; and >34 severe depression. In the CYB003 study, mean baseline total scores on the MADRS were 32.6 and 33.3 in the active and placebo groups, respectively.”

According to the company, trial participants showed “rapid and statistically significant improvements in depression symptoms observed after single doses of CYB003,” along with improvements “in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter.”

Moreover, Cybin said that “CYB003 was well tolerated with no drug-related Serious Adverse Events,’ and that all adverse effects “were mild or moderate in intensity and resolved spontaneously without intervention.”

Doug Drysdale, the chief executive officer of Cybin, said that the results showcase the potential of CYB003 for patients. He said that the results also pave the way for even more robust trials next year.

“The overwhelmingly positive interim results for the 12mg dose of CYB003 are extremely encouraging for patients and providers. The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments,” said Drysdale. “With these encouraging results in hand, we look forward to sharing the full complement of topline data later this quarter, and 12-week durability data in the first quarter of 2024. Our planning continues as we prepare for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD.”

He added: “These positive interim safety and efficacy results support progressing to pivotal studies. We plan to request an end of Phase 2 meeting with the FDA in early 2024 to align on Phase 3 trial design, and we are commencing dosing with a capsule formulation of CYB003 in the bioequivalence cohort and further manufacturing of GMP materials that will be dose flexible, patient friendly and commercially scalable. This is an exciting time – not only for Cybin, but for the entire psychedelics sector – as we now have interim results showing a significant improvement in depressive symptoms with a single dose, moving us ever closer to delivering on our mission to improve the treatment landscape across the spectrum of mental health disorders.” 

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Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms.” 

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

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A clinical trial was recently launched by the Cannabis Research Institute of South Africa (CRI), in partnership with Releaf Cannabis E-Clinics, with the goal of observing how medical cannabis can help treat opioid addiction.

The duration of the trial will last for one year as it examines how cannabis affects a patient’s chronic pain. According to Business Tech, results will be provided to “relevant authorities” who can use that information to regulate medical cannabis in the country.

The trial will be led by Dr. Shiksha Gallow, who will be working with her team to conduct the study. “While the South African Health Products Regulatory Authority (SAHPRA) does not yet have any official cannabis-containing medicines approved for pain relief, anecdotal evidence and preliminary studies point towards its potential to be highly effective in pain management,” Gallow said.

Gallow explained that chronic pain is defined as lasting longer than six months. Treatments for chronic pain include opioids such as morphine, oxycodone, and codeine, which tells a patient’s opioid receptors to block pain messages sent by the body. However patients develop a tolerance over time, so the medication only works for a while, until medication doses must be increased. “Opiates are associated with many side effects, including sedation, respiratory depression—and even death,” Gallow said. “With the global increase in opiate addiction, which brings far-reaching repercussions—from ill health to broader societal issues such as crime—the research will be focused on establishing a safer alternative to treating pain.”

CRI is working with Releaf Pharmaceuticals to study cannabis and find safer medical options for patients. The company’s Managing Director, Willco Janse van Vuuren, expressed their excitement for launching this study. “At Releaf Pharmaceuticals (a proud member of the ImpiloVest Group), we believe being well is a basic human right. Social, mental and physical health is at the heart of everything that we do. We are proud to be working with Dr Shiksha Gallow and the Cannabis Research Institute of South Africa in this ground-breaking study to find natural solutions to pain management that are safe and effective,” said van Vuuren on LinkedIn.

While opioid addiction has caused the deaths of thousands of people, there is evidence that medical cannabis can help treat chronic pain without risk of addiction or overdoses. Bella Dorrington, Senior Researcher at CRI, believes that this study has a lot of potential to help people. “This study aims to emphasize the benefits of cannabis treatment. South Africa is poised to set a standard for medicinal cannabis in the world’s market as we have the resources, technology, and people to make it happen,” Dorrington said.

In June 2022, South Africa’s first clinical trial was launched by Labat Africa and its subsidiary, Biodata, who are also working with Gallow. Referred to as the “Pharma Ethics Observational Study,” this study is also analyzing how medical cannabis can help replace opioids for chronic pain. The study is working with 1,000 patients who have been taking prescribed opioids for at least three months, and are being given the cultivars Tallyman and Exodus (provided by Labat-based Sweetwaters Aquaponics). The strain called 9 Pound Hammer was also being grown for this use by Sweetwaters Aquaponics, which is known for its high THC and CBG cannabinoid percentages.

Like many places in the U.S., South African researchers are also examining how psilocybin can be used for medical treatments. In June, a study launched to investigate how the substance can help treat women with HIV and depression.

South Africa has gradually been developing as a cannabis destination. In July 2022, a township in Johannesburg (located in the semi-northern part of the country) was home to a three-day cannabis festival.

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