Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

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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DMT for Depression? Clinical Trial Finds Hallucinogen Significantly Reduces Symptoms

As we venture further into this new era of psychedelic innovation and discovery, more folks are becoming aware of the potential benefits of substances like psilocybin, LSD, or ketamine. But what about dimethyltryptamine, or DMT, an active chemical in the hallucinogenic plant brew ayahuasca?

U.K.-based biotech company Small Pharma is conducting the first major study of DMT and its potential for treating major depressive disorder (MDD). The company, which focuses on short-duration psychedelic-assisted therapies for mental health conditions, completed its Phase IIa clinical trial, finding a “significant and clinically relevant reduction in depression symptoms” two weeks after dosing, compared to the placebo group, according to a news release.

“SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57% at three months following a single dose of SPL026,” said Dr. Carol Routledge, Small Pharma’s chief medical and scientific officer.

Because of DMT’s short hallucinogenic duration, it’s possible the substance could be an even better clinical alternative to other psychedelics requiring longer treatment sessions. 

The trial, and one of the largest for a short-acting psychedelic, involved 34 patients with moderate to severe MDD, and those who were already medicated were withdrawn from treatment prior to dosing. Participants were given a short IV fusion of 21.5 mg of intravenous DMT, resulting in a 20 to 30-minute psychedelic experience. 

The two-phased study also included a blinded, randomized, placebo-controlled phase, where the primary endpoint assessed the DMT group versus the control group at two weeks post-dose. All participants were enrolled into an open-label phase of the study, which enabled the assessment of the “durability of the antidepressant effect,” along with comparative efficacy and safety of a one-dose versus a two-dose regimen of DMT.

Researchers said, following analysis of key secondary endpoints, that there was a rapid onset of antidepressant effects one week post-dose, though no apparent antidepressant effect was observed between a one- and two-dose regimen of intravenous DMT.

The intravenous dose of DMT was also well tolerated by all patients who received an active dose, with no drug-related serious adverse events, including suicidal ideation or behavior, reported. 

“The results are exciting for the field of psychiatry,” said Dr. David Erritzoe, a clinical psychiatrist at Imperial College London and chief investigator of the Phase I/IIa study. “For patients who experience little benefit from existing antidepressants, the potential for rapid and durable relief from a single treatment, as shown in this trial, is very promising.”

Small Pharma CEO George Tziras also spoke to the potential impact of the trial’s results, particularly for those hundreds of millions of people who live with MDD worldwide. Citing the greater confrontation of psychedelic medicine, addressing the decades of failure on behalf of pharmaceutical drugs, Tziras said the “scale of unmet needs” merits the further investigation of other more effective remedies.

“Our goal is to develop proprietary, scalable and reimbursable short-duration psychedelics with supportive therapy to address this need,” Tziras said. “I am delighted with our top-line results, which demonstrate proof-of-concept for SPL026 and provide encouraging support for our broader portfolio. I want to thank each patient who took part in this trial, as well as their families, the trial investigators, the employees of the trial sites and everyone who has supported the successful completion of this study.”

Research surrounding DMT, and ayahuasca, is still limited—as is psychedelic research surrounding mental health in the grand scheme—though it’s slowly beginning to amp up, as similar studies boast promising results for psychedelic treatment of otherwise treatment-resistant mental health conditions.

One recent study found that ayahuasca use, although a different experience than that of Small Pharma’s study participants, resulted in a high rate of adverse physical effects and challenging psychological effects, though they were generally not severe. In fact, the study found that many participants continued to attend ceremonies and generally perceived that the benefits overshadowed any adverse effects—88% of people surveyed considered adverse effects as an expected part of the process of growth or integration.

Next up, the detailed results of the Phase IIa trial are expected to be presented at upcoming scientific meetings and published in a peer-reviewed journal. 

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MDMA Treatment for PTSD Shows Promise in Clinical Trial

A biopharmaceutical company dedicated to psychedelic treatment announced last week that its clinical trial on MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”) produced encouraging results.

The company, MAPS Public Benefit Corporation, said that it had completed “confirmatory phase three” of the multi-site study, which “met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (‘CAPS-5’) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (‘SDS’).”

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. 

Last week’s announcement comes after the company said in November that it had completed “the second of two Phase 3 pivotal trials.” 

“Now with two positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year,” Emerson said last week. 

The study, known as “MAPP2,” was “a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD,” the company said last week.

“The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more than half of those enrolled in the study,” the company said in a press release. 

Founded in 2014, MAPS Public Benefit Corporation says that its vision is to create a “world where all people have opportunities to heal and grow through psychedelic medicines and therapies.​”

The company’s mission statement reads: “Lead the research, development, and integration of psychedelic medicines and therapies into the healthcare system, prioritizing purpose over profits.​”

That mission has been buttressed by the the U.S. Food and Drug Administration, which in 2017 “granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies,” the company said in last week’s press release.

“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Emerson said in 2017. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

The company said last week that it “expects to submit the new drug application to the FDA in the third quarter of 2023.” 

“MAPS PBC plans to submit the full data set for publication in a peer-reviewed journal,” the press release said. “MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.”

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Clinical Trial Finds Cannabis Oil is Well-Tolerated, Effective Insomnia Treatment

Many will attest, alongside myriad additional studies, to the sedative, relaxing qualities of cannabis as a sleep aid. Now, a new study published in the Journal of Sleep Research adds additional insight surrounding the benefits of cannabis for treating insomnia, finding that the short-term use of plant-derived cannabis extracts is well-tolerated and effective for patients diagnosed with insomnia.

Insomnia involves difficulty falling or staying asleep and is relatively common, experienced by up to 30% of the general population. In their introduction, the authors point to the potential for cannabis to help alleviate sleep dysfunction along with the impact of individual cannabinoids on sleep. Specifically, they reference the sedative effect of THC and the potential of CBD as a sedative in higher doses.

The trial looked to assess the tolerability and effectiveness of medicinal cannabis oil on sleep in adults with insomnia. The study was conducted between May 2020 and May 2021 at the National Institute of Integrative Medicine in Melbourne, Australia. Researchers assessed the use of a cannabis oil product, versus placebo, in 29 subjects with chronic insomnia. 

Each extract contained 10mg of THC and 15mg of CBD per milliliter, along with a lesser amount of other cannabinoids and naturally occurring terpenes, and each participant consumed either the extract or a placebo for a two-week period. Participants were instructed to take the oil in the evening with food, increasing their doses by 0.1ml (1mg THC/1.5mg CBD) increments each day, starting with 0.2ml on the first day and maxing out at 1.5ml (15mg HC/22.5mg CBD).

The six-week study consisted of a one-week run-in period, a two-week intervention period, a one-week wash-out period and a second two-week intervention period, with four total assessments taken at the start and completion of each intervention phase. Primary outcome measures included saliva midnight melatonin levels and insomnia symptoms assessed by the ISI questionnaire.

Ultimately, investigators reported that participants using cannabis extracts experienced improved sleep quality by up to 80%, and 60% of participants were no longer classified as clinical insomniacs at the end of the two-week intervention period. Four of the total participants (14%) had no side effects, while 24 (83%) reported non-serious side effects, possibly related to the active medication, like dry mouth, diarrhea, nausea and vertigo. 

Researchers also noted that, aside from dry mouth, all side effects were only experienced on one or two non-consecutive days. About half of the participants in the active group reached the maximum dose over two weeks, though 20% stopped increasing their dose at 0.4-0.6ml due to side effects like vertigo or dizziness. Two participants reported more serious side effects, acute onset tachycardia (accelerated heart rate) and extreme dizziness, both of which were alleviated by lowering the dose.

At the conclusion of the trial, all but one participant (96%) found that cannabis oil was an acceptable treatment for insomnia, and the majority of participants (79%) requested an ongoing prescription for the medicinal cannabis oil, even the participant who had tachycardia. Five of the six participants who chose not to continue taking the cannabis oil cited reasons other than side effects (like work restrictions, driving a vehicle) for discontinuing treatment.

“Our short-term trial suggests Entoura 10:15 medicinal cannabis oil, containing THC:CBD 10:15 and lesser amounts of other [cannabinoids] and naturally occurring terpenes, to be well tolerated and effective in significantly improving sleep quality and duration, midnight melatonin levels, quality of life, and mood within 2-weeks in adults with insomnia,” researchers concluded. “Long-term studies are needed to assess whether chronic medicinal cannabis intake can restore natural circadian rhythm without the need for ongoing cannabis intake.”

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Another Medical Cannabis Clinical Trial Launches in South Africa

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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North America’s First Take Home Psilocybin Trial Approved in Canada

A pharmaceutical company called Apex Labs announced on Nov. 1 that it will be conducting the first North American take home multi-dose psilocybin clinical trial. Apex Labs is a patient-driven pharmaceutical company that specializes in psilocybin treatments for military veterans.

According to a press release, the trial known as APEX-002-A01-02 will explore the efficacy of APEX-52 (psilocybin) for veterans suffering from depression and post-traumatic stress disorder. Apex Labs received a “no objection letter” from Health Canada on October 24.

The veteran patients will receive low-dose, multi-dose psilocybin for oral use, which received Good Manufacturing Practice certification, and will be given to patients in a labeled package with at-home instructions.

Apex Labs CEO Tyler Powell is excited to introduce this medicine to patient participants, allowing them a safe way to explore if psilocybin can help treat their medical conditions. “This approval signals a willingness from Health Canada to allow APEX to move forward with a clinical pipeline focused on Veteran patients with PTSD and a comorbid diagnosis of depression,” Powell said. “Veterans are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming. Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need.”

There’s evidence that psilocybin can be effective in treating numerous conditions and disorders. In 2019, the U.S. Food and Drug Administration (FDA) gave “Breakthrough Therapy Designation” to Usona Institute in Wisconsin for its work on psilocybin to treat major depressive disorder. Such a designation shows that the FDA is committed to fast tracking drug review and development.

Similarly, on Jan. 5, 2022, Health Canada amended its Controlled Drugs and Substance Act through its Special Access Program, expanding to include psilocybin and MDMA. “There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin that have been granted “breakthrough therapy” designation by the United States Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively,” Health Canada wrote.

Powell is proud of the opportunity his team will have to help veterans in this first-ever at-home trial. “It is beyond satisfying to know that our team’s hard work has led to the first Canadian Veteran patient taking APEX-52 in the comfort of their own home,” Powell said. 

Just recently, the University of Guelph in Ontario, Canada was approved to conduct a study on psilocybin mushrooms. The university received a “dealer’s license” from Health Canada on Oct. 25, making it one of the first universities in the country to receive such approval.

In the U.S., voters will soon choose whether or not to approve psilocybin. In Oregon, psilocybin was approved via ballot initiative in 2020, but this year it will be on the ballot again in 27 of the state’s 36 counties. Meanwhile, the Oregon Health Authority recently adopted the first round of rules for psilocybin in May 2022, and the final rules are set to be adopted by December 30, 2022. There is currently a public comment period running from Nov. 1-21.

Voters in Colorado are also voting on psychedelic legalization and psilocybin therapy centers with Proposition 122. According to military veteran Kevin Matthews, who is also the coalition director of Natural Medicine Colorado, believes that the approval of this initiative would help countless people. “They changed my life. The clouds parted. I realized that I no longer had to be a victim to my diagnosis of major depression,” Matthews told the Colorado Sun. “Colorado is in a mental health crisis right now. We want to make sure that all Coloradans have access to this at some level, especially our veterans and those with extreme trauma.”

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