Press Release: Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin)
OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into safe, effective and licensed medicines, today announced that it had received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a global multi-site Phase IIb study exploring the safety, efficacy and tolerability of two distinct doses of its lead compound, BPL–003, in patients with Treatment Resistant Depression (TRD).
BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device. This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment. The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.
Phase I datahas already shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences, which might be correlated with positive clinical outcomes, with a rapid onset of psychedelic treatment effects within minutes. All perceptual effects were resolved within 60-90 minutes.
Beckley Psytech’s Phase IIb randomised, dose-finding study will evaluate the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate to severe TRD who are not taking concomitant antidepressants. The study will be quadruply masked, with the patient, investigator, attendant and outcomes assessor all blinded to the dose allocation of the subject to reduce expectancy bias. Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial.
The Phase IIb study, which is fully funded from Beckley Psytech’s existing cash reserves, will complement the Company’s ongoingPhase IIa study of BPL-003 for TRDand initial results are expected in 2024.
Commenting on the IND approval, Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said:“This is a critical step towards our mission of delivering safe, effective and licensed psychedelic treatments to patients in need, and is also a significant milestone in the evolution of our clinical pipeline. It’s a privilege to be given the FDA’s first IND for a Phase IIb study of 5-MeO-DMT and it provides firm validation of the positive preclinical and Phase I data we have generated so far with BPL-003. This is an important step not only for Beckley Psytech, but also for the whole field of psychedelic drug development and, most importantly, for patients who are in urgent need of more effective treatments for mental health conditions such as depression.”
It is estimated that nearly300 million peoplearound the globe have depression but, for many of those living with the condition, even the best current medicines either do not work or have side effects that leave them unable to experience life to the fullest.33% of patients are resistant to available treatments, such as selective serotonin reuptake inhibitors (SSRIs), and60% of patientsdiscontinue or switch SSRIs within 12 weeks due to side effects.
Beckley Psytech’s Chief Medical Officer, Dr Frank Wiegand, also said:“The distinctive characteristics of BPL-003 make us optimistic about the compound’s potential to be a safe and effective alternative to currently available antidepressants. The rapid onset of effect, as well as the reliable induction and short duration of profound psychedelic experiences, are of great interest to us and we are excited to assess the therapeutic benefits of BPL-003 more deeply in this study”.
The numerous benefits of psychedelics have been coming to light in recent years, and women are taking notice. With little options in the way of pharmaceutical drugs, especially when it comes to treating mental illness and hormonal imbalances, it’s no surprise that women are experimenting with hallucinogens to see what can actually help. And better yet, a recent study found that psilocybin can help regulate menstrual issues. Let’s dig deeper into how and why psychedelics are so valuable for the fairer sex.
Women and psychedelics
The psychedelic renaissance is in full swing, and women are at the heart of it. After decades of prohibition and condemnation (following a brief period of them being studied and used medicinally), the western world is finally starting to reexamine the many therapeutic benefits of these substances. LSD, Ketamine, MDMA, and psilocybin have been undergoing various clinical trials to see how they can be utilized to address a growing mental health crisis in the United States.
Jennifer Gural, a psychotherapist from Los Angeles, California, commented about how hallucinogens have helped change her life, and how she began using them to help her female patients as well. “It shifted the focus of my life,” she stated. “It really helped me to tackle how my brain works and how I was thinking … It was such a profoundly life-changing experience. I have done ayahuasca and I’ve done psilocybin. I don’t know if I’ll ever do it again, but I’m open to that if it’s needed—which I think is how we should use psychedelics.”
While there seems to be a recent influx of ladies trying psychedelics, self-medicating is nothing new for women. This could stem from frustrations with our existing health-care system, and how it has been historically geared toward treating men and either dismissing our issues or over-medicating us.
As women – daughters, mothers, sisters, grandmothers, wives, friends – we have many struggles that we are often forced to face alone. Women are more likely to suffer from PTSD than men – particularly women of color, transgender, and gender-diverse individuals. Women also deal with depression and anxiety more often, and one in seven women have postpartum depression after childbirth.
New studies have found that even a couple experiences with psychedelics, especially when combined with talk therapy, can lead to lifechanging, psychological developments. As a matter of fact, MDMA and psilocybin have been labeled as “breakthrough therapies” by the FDA, a designation given to “promising drugs proposed to fill an unmet need”. With so many pharmaceutical antidepressant and antianxiety drugs on the market, and the number of mental disorders still rising, we can clearly see that treating our troubled human minds is that unmet need.
Is this the beginning of a brighter, more beautiful future for women’s healthcare? One where common mental illnesses, chronic pain, and hormonal conditions are treated successfully with psychedelic trips, rather than a lifetime of pharmaceutical medications? It seems quite promising.
The new research on psilocybin and estrogen
Although no clinical trials have been conducted, researchers from John Hopkins University have been looking over case files and anecdotal reports on women and psychedelics, and how estrogen can change the effects of psilocybin specifically. We know that estrogen can impact binding at serotonin receptor sites, and because most hallucinogens interact with serotonin receptors as well, experts believe that our cycles can influence how psilocybin works in our bodies, and vice versa, the psilocybin itself can have an impact on our hormones.
Based on the aforementioned case studies, researchers discovered that psilocybin seemed to help regulate menstrual cycles. One of the women studied had premenstrual dysphoric disorder, which is a very severe form of PMS, and she used psilocybin to help regulate it. In another case, a woman suffered from polycystic ovarian syndrome and was having irregular periods. At one point, menstruation completely stopped for a while, but after taking psilocybin, it came back.
“Our menstrual cycles occur along the hypothalamic-pituitary-gonadal (HPG) axis, so as one hormone kicks off, it tells another hormone what to do in this feedback loop and that’s the trajectory of our menstrual cycles,” says Jennifer Chesak, author of The Psilocybin Handbook for Women. “We also have the axis that manages our stress response, the hypothalamic-pituitary-adrenal (HPA) axis. These two axes sort of overlap, and so they each impact one another. When we use psilocybin, we are at doing something along that stress response along the HPA axis.”
Chesak added: “We already know from research outside of psychedelics, that these two axes do impact each other: our stress response can impact our cycle, and our cycles can impact our stress response. So, it’s not a stretch to think that when we are using psilocybin, that something is going on with our stress response that then impacts the menstrual cycle”
Although we only have these few case studies and anecdotal reports at the moment, the results are telling. And it begs the question of when we can see a real clinical trial on this topic, so we can better understand the mechanisms of how it works from a scientific perspective.
Aside from medical benefits, do women experience psychedelics differently than men?
Honestly, who really knows? Obviously, no studies have been done on whether women trip differently than men. But it’s possible that because women tend to be more emotional, empathetic, and receptive to spiritual experiences – this could be beneficial to producing better and more positive, even more therapeutic highs.
Historically, statistics indicate that men use more drugs than women – and this across the board, from illicit drugs to legal substances like tobacco and alcohol. And since most research is still conducted on male subjects, female drug use patterns and their subsequent experiences remain somewhat of an enigma.
However, we do know that in general, psychotropic drugs impact women differently than men, but sex-based responses to medications are often overlooked. It wasn’t until the 1990s that women were even allowed to participate in clinical trials in the United States, and many studies are still done using a larger number of male participants.
Despite this, women are twice as likely as men to be prescribed psychotropic medication (back to that overmedicating issue), and recent research shows that factors like different hormones, body composition, and metabolism can cause different drug-reactions. For example, the sleep medication Ambien was found to be twice as potent for women.
Additionally, experts claim that women are “between 50 and 75 percent more likely to experience side effects”. An analysis of existing clinical trials published June 5, 2020, in the journal Biology of Sex Differences, authored by Prendergast and Irving Zucker of UC Berkley, they noted 86 drugs which presented “clear evidence of sex differences in how the body broke down the drug.” They found that “For nearly all of these drugs, women metabolized them more slowly than men, leading to higher levels of exposure to the drug; in 96% of cases, this resulted in significantly higher rates of adverse side effects in women.”
Final thoughts
To reiterate, because the foundation of modern medicine is structured around research performed almost exclusively on men, most of what science tells us about the prevention, diagnosis, and treatment of illness may not be applicable to women. With so much of our population feeling like they are not understood by healthcare professionals, it’s no surprise that a growing number of women are self-medicating with cannabis, psychedelics, and other natural, alternative solutions.
As we learn more about how psilocybin and other hallucinogens interact with female hormones, we can better understand how to use these incredible products to improve our health, and our lives.
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When we think of trippy cacti, mescaline generally comes to mind. And rightfully so, as very few other cactus compounds are truly psychedelic. That being said, most people tend to associate mescaline with peyote, but peyote is illegal in the United States. What many don’t realize is that many other, completely legal cactus species contain mescaline also. Let’s learn more about a few of the more popular varieties.
What is mescaline?
Mescaline (3,4,5-Trimethoxyphenethylamine) is a naturally occurring, plant-based psychedelic protoalkaloid belonging to the phenethylmine class. Like other drugs from this class, mescaline has an affinity for serotonin receptors. Although it binds to virtually all serotonin receptors in the brain but has a stronger affinity for the 1A and 2A/B/C receptors.
Aside from Peyote, which is the most well-known, mescaline can be synthesized from a few other cactus species as well, a few of which we’ll discuss in further detail later on. It’s known for its powerful hallucinogenic properties, comparable to those of LSD and psilocybin.
Mescaline
A common dose for mescaline is roughly 200 to 400 mg, depending on the person’s size, level of experience with the compound, and other factors. Traditionally, San Pedro dosing is calculated at roughly 3.75 mg/kg of weight. However, potency can vary wildly from cactus to cactus, so it can be quite difficult to get consistency in dosing. For example, 50 grams of powdered cactus can have anywhere from 150 mg to 1,150 mg of mescaline. Factors such as where and how the cactus grew (the plant’s terroir) and access to water and sunlight can influence the plant’s potency.
Mescaline produces a number of effects, including intense hallucinogens, with both open and closed-eye visuals; distortion in time, sound and vision; an increase in introspective and conceptual thinking; the loss of ego; and feelings of euphoria. It’s often considered gentler than other psychedelics with less negative come-down, while possibly producing greater insight than these other compounds. It’s the subject of a growing body of research for its potential medical properties.
Mescaline has a rich history of traditional and spiritual use dating back thousands of years. Native Americans have long used peyote as a religious sacrament and in the early 1800s (aka Peyotism), the modern-day Native American Church (NAC) was formed. The 1994 amendment to the American Indian Religious Freedom Act legalized the use of peyote for members of this church. However, it’s banned for everyone else in the United States.
Mescaline-producing cacti
Many cacti are known to be psychoactive, containing phenethylamine alkaloids such as mescaline, or other mind-altering compounds. Cacti that produce mescaline specifically, can be found growing throughout North and South America, with more prominence in certain areas such as most of Mexico and the Andes region which stretches throughout Venezuela, Colombia, Ecuador, Peru, Bolivia, Chile and Argentina.
The two genera that are most often used for spiritual and ritualistic purposes are Echinopsis, which contains the San Pedro cactus group; and Lophophora, which has peyote. Several other species contain mescaline and are just as potent, but do not have the same historical background.
Peyote
Peyote (Lophophora williamsii), or “the sacred one”, is by far the most well-known of the mescaline cactus types. It’s been talked about in movies, literature, and music, and also depicted in many types of visual artwork such as paintings and photographs. It’s a very slow-growing, spinless, flowering, button cactus that is greenish-blue in color, sometimes with hints of grey.
Peyote cactus buttons
The Peyote cactus grows among thorny shrubs in the high desert regions of Central Mexico to Southwestern Texas, mainly between 330 and 4,920 ft, although in some rare circumstances, it has been found at elevations as high as 6,200 feet.
It’s a very hardy plant that can grow in many different types of increment weather conditions. Mainly, it just needs that dry desert air. It’s common to find it growing on or near limestone hills. It flowers in between March and May, and the flowers are pink and white with thigmotactic anthers. It grows in the wild from central Mexico to Southern Texas.
In traditional peyote preparations, the top of the cactus is cut off, leaving the large tap root along with a small, green photosynthesizing area where new heads can grow. These heads are then dried to make disc-shaped buttons. The buttons are chewed or soaked in water to make a beverage. An average dried button weighs about 2 grams, and it would take 6-10 buttons to produce psychedelic effects. Peyote is extremely bitter though, so more contemporary users will usually grind the dried buttons into a powder and pour into capsules to consume.
San Pedro
San Pedro (Trichocereus/Echinopsis pachanoi) is a tall, thin flowering columnar cactus that grows in clumps. Each column has 7-9 ridges with small clusters of spines along the edges. The clump can grow up to 14 feet tall and contain a substantial amount of mescaline. It hails from the Andes Mountain region of South America. It also grows well in the Southwestern US, as far north as Colorado, although it truly thrives in California and Arizona, where it can be seen with regularity in residential areas and shopping centers.
San Pedro cactus columns
Their fast growing nature has seen San Pedro cacti become very popular in the last decade, although it too steeped in history. Use of San Pedro can be traced back to the pre-Columbian Chavin culture that developed in Peru between 1300 to 200 BCE. This is evidenced by numerous stone carvings depicting mythical beings holding San Pedro cacti, the oldest of which was discovered in an old temple at Chavin de Huantar in the northern highlands of Peru. Numerous other artifacts from the region bore San Pedro symbolism as well, and perhaps the most concrete proof of its use are the 3,000-year-old cactus cigars found in the same cave as the carvings.
Even today, San Pedro is sold at numerous markets in the country and in 2022, the Peruvian Ministry of Culture declared the traditional use of San Pedro cactus in northern Peru as part of their cultural heritage. Traditionally, San Pedro can be consumed either on its own or mixed with other plants in a psychedelic, ceremonial brew called cimora.
It can also be bought online or at gardening stores in the US with relative ease because it’s federally legal. And because there are now laws against possession of San Pedro, it’s one of the longest-studied psychedelics, as well as the first cactus to be labeled with the term (psychedelic). Dosing can be challenging as potency varies considerably. There are San Pedro that are completely inactive and won’t do anything, and there are some that are strong enough that you only need a couple inches of fresh plant to feel a good high – so there is a certain level of trial and error involved to figure out what is best for each person.
Peruvian Torch
Peruvian Torch, or Trichocereus Peruvianis, is often confused for San Pedro but it’s slightly different. It’s distinguished by its blue shade and longer spines. Not only are the spines longer, but they’re also a different color – San Pedro spines are yellow, whereas the Peruvian Torch spines start off as a brownish-yellow and turn to bone white as they age.
Blue Peruvian Torch cactus with brownish/yellowish spines
Additionally, Peruvian Torch is said to be much more potent than San Pedro, although honestly, it’s hard to find any reliable information on this other than word-of-mouth and reddit posts. It seems that, although some of the highest recorded concentrations of mescaline have been from San Pedro cactus varieties, so have some of the lowest. Peruvian torch seems to be more consistent on the higher end.
Bolivian Torch
Bolivian Torch, or Echinopsis lageniforis, is another fast-growing columnar cactus that bears many similarities to San Pedro and Peruvian Torch. Origins of its use can be tracked back to the indigenous shamans of La Paz, Bolivia, who would refer to this cactus as “Achuma” or “Wachuma”.
Bolivian Torch has much higher levels of mescaline than both Peruvian Torch and San Pedro with roughly 0.56 percent by dry weight, although concentrations did vary a bit based on the location of the cactus. All you need is about 0.3 to 0.4 grams to produce the desired effects, which is typically a noticeable psychedelic experience. They also get quite tall, up to 15 feet and some of the mature ones produce a big, blooming flower right on the top.
Bolivian Torch
Interestingly, they still are not as popular as one would expect, given the benefits of choosing this cactus over other mescaline producing varieties. One reason is because they simply are not very well known. Another reason is because people often use the names Bolivian Torch, Peruvian Torch, and San Pedro interchangeably, believing they are all different terms for the same cactus when in fact, they only look similar and all contain mescaline.
Other psychedelic cacti
There are roughly 300 cactus types that produce psychoactive compounds. It’s usually mescaline, but not always; although the other psychedelic cacti are even less researched than the mescaline ones, so very little is known about the potential of these agents. There could be several hallucinogens in these cacti that are yet to be discovered.
Another species of cactus, the Echinocereus triglochidiatus, is suspected to contain a tryptamine-derivative that is similar to 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine), although again, there is not much literature on the subject.
Some other fairly well-known psychoactive cacti (among psychonauts and botanists at least) are Ariocarpus species with numerous phenethylamines, which are often referred to as “maddening drugs”. However, the mechanisms of how these compounds work is still not very well understood. Additionally, some cacti contain stimulants, and others contain compounds that can be used for pain relief.
Final thoughts
Plants are fun, and while trying to research psychedelic cacti it becomes abundantly clear that there is so much in nature that we still know nothing about. A lot of cacti contain mescaline, and we’re now learning that several contain other psychoactive compounds, many of which have yet to be studied in any capacity. It’s exciting to think what the future of psychedelics holds.
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Summary: Researchers are exploring the potential of yeast fermentation as a sustainable method for large-scale psilocybin production, a compound found in “magic mushrooms” that has shown promise in treating various mental health conditions.
Yeast Fermentation: A New Frontier in Psilocybin Production
The global mental health crisis has intensified the search for effective treatments, and psilocybin, a hallucinogenic compound in “magic mushrooms,” is emerging as a promising candidate. With the potential FDA approval of psychedelic medical treatments on the horizon, there’s a growing need for sustainable and large-scale production methods for psilocybin.
In a significant development from the Novo Nordisk Foundation Center for Biosustainability at the Technical University of Denmark in 2020, scientists successfully produced psilocybin using Saccharomyces cerevisiae, a yeast commonly used in beer fermentation. This innovative method involves genetically engineering the yeast with genes from the Psilocybe cubensis mushroom. When fermented with sugar, tryptophan, and other nutrients, the yeast produces psilocybin.
This approach is not only more environmentally friendly but also sidesteps the expensive and harmful by-products associated with the current synthetic production of psilocybin. However, this breakthrough also brings challenges. There are rising concerns about the potential misuse of this method for illicit homebrewed psilocybin, especially after researchers demonstrated psilocybin production using genetically modified E. coli bacteria in a homebrew setting in 2021.
This development underscores the importance of robust regulations to ensure that psilocybin production remains dedicated to medical research and treatment.
And we would like to know what regulatory measures are essential to prevent the illicit homebrewing of psilocybin or, even better, shouldn’t we stop fighting the use of recreational drugs and start regulating them… Afterall, while using drugs carry risks, at the same time, they provide many benefits so a smart regulator sould rather control it, that create a black market by trying to stop it.
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AI Disclaimer: This news update was created using a AI tools. PsychePen is an AI author who is constantly improving. We appreciate your kindness and understanding as PsychePen continues to learn and develop.Please note that the provided information is derived from various sources and should not be considered as legal, financial, or medical advice.