An ayahuasca retreat could make you more empathetic!
In a recent study, participants reported reduced stress, anxiety, and depression after attending an ayahuasca ceremony… even those who were given a placebo.
However, only the ayahuasca users showed increased empathy.
The supportive group atmosphere could explain why people experienced benefits even without taking ayahuasca.
Allied Corp. (ALID) sourced the active ingredients to produce Psilonex™, its formulation of psilocybin, functional mushrooms, and vitamins. It will be used in conjunction with a daily dose of CBD in an upcoming clinical trial on depression, anxiety, and PTSD.
San Diego, California–(Newsfile Corp. – November 2, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company“), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that it has submitted an Investigational New Drug (“IND“) application to the U.S. Food and Drug Administration (“FDA“) to evaluate its clinical candidate, TRP-8802, in a Phase 2a clinical trial that investigates safety and preliminary effectiveness of psilocybin-assisted therapy among patients with fibromyalgia in collaboration with the University of Michigan.
The trial is being conducted with Kevin Boehnke, Ph.D. from the University of Michigan and will evaluate the Company’s oral formulation of synthetic psilocybin, TRP-8802, in combination with psychotherapy. The application includes details regarding the trial protocol and safety information. Tryp expects to initiate the Phase 2a study in 2022 subject to a favorable review of the IND by the FDA.
“Many fibromyalgia patients find insufficient relief from the currently available, FDA-approved treatments for the disease due to their limited efficacy and significant side effects,” commented Dr. Boehnke. “We have an opportunity with Tryp to conduct a Phase 2a study that evaluates the safety and clinical utility of psilocybin for fibromyalgia as we target the origins of the disease rather than simply treating patient symptoms.”
The Phase 2a open label clinical trial is expected to enroll 20 fibromyalgia patients and includes a variety of exploratory endpoints given the high prevalence of co-morbidities such as poor sleep quality, depression, anxiety, and other conditions. The administration of psilocybin is expected to increase neuroplasticity and to address disrupted neural connections that are typical of fibromyalgia and other nociplastic pain indications. Patients will meet with psychotherapists before, during, and after the dosing of TRP-8802.
“We have been working diligently to complete this IND submission and are eager to initiate what will be one of the first evaluations of psilocybin to treat fibromyalgia in a Phase 2 study,” said Greg McKee, Chairman and Chief Executive Officer of Tryp. “Through our close collaboration with Dr. Boehnke and other experts in the space, we have an appreciation of the limitations of current treatments for this disease and a determination to develop a more effective therapy for the millions of patients suffering from fibromyalgia.”
About Tryp Therapeutics
Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and other indications. The Company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and overeating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and route of administration to improve the patient experience. For more information, please visit www.tryptherapeutics.com.
Investor Relations:
Joseph Green
Edison Group
investors@tryptherapeutics.com
Media Relations:
Abby Berger
KCSA Strategic Communications
TRYP@KCSA.com
Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
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This Australian university just got the go-ahead to conduct a first-of-its-kind study!
Yesterday, Monash University received ethics approval for a triple-blinded, active-placebo-controlled study that will investigate psilocybin-assisted psychotherapy as a treatment for severe Generalized Anxiety Disorder (GAD).
Researchers are looking to recruit 72 patients for the study, which will be conducted in partnership with Incannex Healthcare Ltd (IHL).
The therapists facilitating the study will have the option to undergo their own psilocybin session to better understand what the patients will experience.
Cybin (CYBN) is sending therapists on a psychedelic retreat so they can learn how to provide support to frontline healthcare workers.
Clinical trial facilitators will head to a small island in Washington to be trained on Cybin’s new EMBARK therapy model and gain experiential knowledge of psychedelics. The EMBARK model combines aspects of several psychotherapy models and incorporates patients’ spiritual experiences, bodily experiences, and relationships into the healing process.
The retreat will prepare the facilitators for an upcoming clinical trial at the University of Washington that aims to treat healthcare workers suffering from COVID-related distress, depression, anxiety, and PTSD.
This week, Cybin Inc. (CYBN) completed its 74th preclinical study to advance its proprietary molecules, CYB003 and CYB004, toward clinical research.
The company has evaluated 50 novel compounds in its preclinical research, narrowing it down to four lead candidates. including CYB003 for alcohol use disorder and CYB004 for anxiety disorders. The formulations are showing faster onset times, shorter durations, high oral bioavailability, significant brain penetration, and less variability between subjects compared to classic psychedelics.
Human clinical trials are expected to commence early next year to work toward an Investigational New Drug (IND) status.
Even non-psychedelic mushrooms could lower your risk of depression!
Researchers from the Penn State College of Medicine collected data from 24,000 Americans and discovered that those who ate mushrooms had a lower chance of being depressed.
Mushrooms are the highest dietary source of ergothioneine, an antioxidant that may prevent mental illnesses by reducing oxidative stress protecting against cell damage.
While the study didn’t factor in different types of mushrooms, white buttons are believed to ease anxiety and Lion’s Mane can promote neurogenesis which may prevent mental disorders.
Could microdosing + this new technology reduce pain in cancer patients?
MindBio Therapeutics is developing a technology platform to integrate with psychedelic therapy to prevent the mental health of cancer patients from deteriorating.
By utilizing wearable devices, the platform is designed to help with pain management to prevent depression, existential distress and anxiety.
MindBio Therapeutics will use the mindfulness app in an upcoming Phase 2 microdosing trial, which is funded by the New Zealand government, to see if it provides additional benefits to late-stage cancer patients compared to microdosing alone.
The company aims to commercialize the application globally and believes the tech has potential to receive government funding in Europe.
A new study found that combining SSRIs and psilocybin is not only safe, but may be beneficial!
Yesterday, MindMed (MNMD) announced the findings from several ongoing studies conducted in collaboration with UHB Liechti Lab.
In one study, psilocybin was found to be safe to administer with an SSRI antidepressant and did not reduce the psychedelic experience. Two weeks prior to the psilocybin dose, volunteers were give a daily pretreatment of the SSRI escitalopram. As a result, the volunteers experienced reduced anxiety and blood pressure increases that occur with psilocybin administration.
Another study compared the perceptual effects of psilocybin to LSD and revealed that a 20 mg dose of psilocybin is equivalent to 100 mcg of LSD.
The company will continue to analyze the study data and will publish additional findings later this year.
Mydecine Innovations Group (MYCO) filed a patent for a new anxiety and PTSD drug that provides more immediate relief than pure psilocybin.
The compound, MYCO-003, combines a serotonin agonist with a serotonin releasing agent – two drug classes that increase one’s sense of well-being, safety, and happiness. The formulation has shown positive preclinical data and has potential to relieve extreme anxiety before needing to provide extensive supportive care, according to the Chief Science Officer.
The patent was filed with both the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization (WIPO).
