Could your next surgery involve MDMA?
Shanti Therapeutics of Global Wellness Strategies (GWS) is preparing for a study to see if MDMA has an impact on pain tolerance in healthy volunteers.
The goal is to treat and prevent perioperative pain, or pain associated with surgery.
Managing pain immediately after surgery can help prevent chronic pain and the mental health issues that often follow.
Highlights:
● Emyria and the University of Western Australia (UWA) have received positive screening
results from the second batch of MDMA analogues sent to Eurofins (EPA:ERF)
● 16 of 17 novel compounds synthesised and screened demonstrated no interactions
with selected “anti-targets” (receptors and enzymes known to be involved in
unwanted side effects); These results bring total count of successfully screened
analogues in the proprietary library to 83 of 85, and growing
● New compound synthesis is ongoing; Third batch of MDMA analogues now being
prepared for initial screening with Eurofins
● Emyria and UWA have also entered into an agreement with a leading contract
research organisation (CRO) to evaluate “drug-likeness” for the partnership’s highest
priority MDMA analogue candidates; Further studies will compliment preclinical
screening work currently being planned with University of Sydney
● Novel MDMA analogue development progressing well alongside Emyria’s cannabinoid
programs, with preliminary EMD-RX5 Phase 1 results to be received end of this week
Emyria Limited (ASX: EMD) (Emyria or the Company), a clinical stage biotech developing
multiple treatments for unmet needs powered by real-world patient data, is pleased to
announce positive progress on its MDMA (aka ‘ecstasy’) analogue development program
being run in partnership with the University of Western Australia (UWA).
Positive screening results grows MDMA analogue library
16 of 17 compounds sent from the second batch of analogues successfully passed screening with Eurofins at the test concentrations, meaning these compounds showed no evidence of interactions with one or more of the enzymes or cell receptors (“anti-targets”) that can be associated with unwanted clinical side effects.
These positive results bring the total count of successfully screened MDMA analogues to date to 83 out of 85. (See ASX release 08 Dec 2021)
Additional preclinical screening is now being planned with a leading CRO who will perform
a number of assays to evaluate the solubility, partition coefficients and metabolic stability of each compound. These assays can help to predict absorption and brain uptake rates and
help identify compounds that are similar to MDMA in potency but with faster onset and
shorter half-lives, which may be more suitable for clinical applications.
Leading MDMA analogues will undergo more sophisticated pharmacokinetic studies, which
is important in helping select compounds for further in vivo efficacy studies.
The MDMA analogue library
Emyria recently secured exclusive rights to a library of more than 100 novel MDMA
analogues (and growing) from the University of Western Australia creating a unique
drug-discovery pipeline. (See ASX announcement 05 Aug 2021)
The analogues are unique chemical entities that are structurally similar to
3,4-Methyl enedioxy methamphetamine (‘MDMA’, ‘ecstasy’) but designed to engage
different neurological targets based on feedback from earlier screening work.
MDMA-analogues have shown promise as next-generation psychedelic-assisted therapies
and treatments for neurological disorders, such as Parkinson’s Disease. For some
indications, it may be desirable to moderate (increase, decrease or remove) the euphoric
and stimulant effects of MDMA. The development program has been designed to create
MDMA-like compounds that are more selective for specific neurological receptors and
with the potential to become treatments for large patient populations.
Each new compound created is guided by prior screening results. Follow-on preclinical
development programs are being planned with key partners to identify which
compounds have the strongest IP and the greatest potential to become either next
generation psychedelic-assisted therapies or treatments for other neurological disorders.
Emyria’s Managing Director, Dr. Michael Winlo said: “Emyria and development partner,
the University of Western Australia, now have a set of over 80 MDMA-like compounds
with strong IP and therapeutic potential.
We are now planning pivotal preclinical studies to help identify which of these
compounds may have the potency of common MDMA but with enhanced safety and
shorter acting times and half-lives. We anticipate this screening program will help
identify compounds with the potential to become registered treatments for other
neuropsychiatric conditions.
This announcement has been approved and authorised for release by the Board of Emyria
Limited.
For further information:
Dr. Michael Winlo Lexi O’Halloran Andrew Williams
Managing Director Investor Relations Media Relations
+61 (0) 8 6559 2800 +61 (0) 404 577 076 +61 (0) 412 614 125
mwinlo@emyria.com investors@emyria.com awilliams@emyria.com
About Emyria (www.emyria.com)
Emyria Limited develops biopharmaceuticals guided by proprietary Real-World Data
collected with patients across its wholly-owned clinical service subsidiary, Emerald Clinics.
Emyria’s current clinical development programs are focussed on the registration of
proprietary formulations of cannabinoid-based medical treatments (CBMTs) and novel
MDMA (‘ecstasy’) analogues with major global regulators. Emyria’s programs target major
unmet needs such as mental health disorders and chronic pain.
Emyria’s Real World Data (RWD) guides each of Emyria’s clinical development programs
and care models. Emyria RWD is deep, ethically-sourced clinical evidence gathered with
thousands of patients who also receive personalised care at Emerald Clinics.
Emyria is therefore uniquely providing care to patients, generating clinical evidence and
advancing multiple proprietary treatment programs towards registration.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the
Company, the company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any
obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
PharmAla Biotech (MDMA) signed a distribution agreement with CCrest Laboratories, making its MDMA available to both international and domestic customers.
The governor of Connecticut signed off on a new budget that will establish psychedelic treatment centers. Patients with serious conditions will be able to try psilocybin and MDMA therapy through the FDA’s expanded access program.
The state will fund treatments military veterans, retired first responders and health care workers 🧡
MAPS announced that its Phase 3 MDMA trial for PTSD is now fully enrolled at 13 sites across the United States and Israel.
The organization took equity initiatives to ensure that BIPOC and LGBTQ+ individuals are represented in the study, as these individuals are more likely to have PTSD (yet less likely to be diagnosed or have reasonable access to treatment).
Bob Parsons, founder of GoDaddy, suffered from PTSD after witnessing “grisly combat” in the Vietnam War.
It wasn’t until he went through a multiday therapy treatment with psilocybin, ayahuasca, and LSD that he began to feel like his old self again.
“What I think psychedelics did was a reset. Now, I’m like people who haven’t been in combat to a certain degree,” he believes.
Bob is on a mission to help other veterans battling PTSD. He donated $5M to Mount Sinai’s psychedelic research center to fund MDMA therapy training for healthcare practitioners.
“I am a completely different person then versus now. My PTSD will always live inside of me, but it’s no longer taking over my life,” says Sarah, one of the participants in MAPS’ MDMA trial.
Sarah endured a traumatic sexual assault that gave her painful flashbacks.
Over three MDMA therapy sessions, she was able to go back to the experience and fill in the gaps in her memory to fully process what had happened in a safe environment. In the final session, she confronted her attacker and was able to find forgiveness for them.
“I felt like I was given freedom from the trauma,” she explains.
Delic (DELC) received a Section 56 Exemption to research MDMA, LSD, DMT, mescaline and 2C-B and acquire 60 grams of psilocybin mushrooms from from Nectar Health Sciences.
Both the Senate and the House of Delegates approved a Maryland bill that would provide veterans with free psilocybin, MDMA, and ketamine treatments for PTSD or traumatic brain injury.
If approved by the governor, the state would devote $1M per year to funding the treatments.
PharmAla’s GMP MDMA will accelerate trial work funded by Australia’s premier Psychedelics charity
VANCOUVER, BC, April 8, 2022 /CNW/ – PharmAla Biotech is proud to have been selected as the MDMA manufacturing partner for Mind Medicine Australia. Mind Medicine Australia’s order will be available for delivery later this year, for use in an ethics approved healthy persons trial and will be subject to all necessary government approvals being obtained.
“We’d like to congratulate Nick and his team for the ground-breaking work that they have done in developing GMP, medical grade MDMA for use in clinical trials and regulatory approved expanded access schemes,” said Peter Hunt, Board Chair of Mind Medicine Australia. “There is a desperate need for innovation in the mental health sector for hard-to-treat illnesses such as post-traumatic stress disorder which cause enormous suffering. Clinical trials have shown that MDMA assisted therapy is safe to use in clinically controlled environments and can achieve high remission rates for people suffering from post-traumatic stress disorder”.
Mind Medicine Australia is a registered charity founded by Tania de Jong AM and Peter Hunt AM in 2019. Mind Medicine Australia supports clinical research and is working towards regulatory-approved and evidence-based psychedelic-assisted therapies being available through the medical system in Australia for patients suffering from relevant treatment resistant mental illnesses including depression and post-traumatic stress disorder. Mind Medicine Australia connects medical practitioners, consumers, academia, government, industry, regulatory bodies, philanthropists, investors and other stakeholders and provides therapist training and clinical support for psychedelic assisted therapies through its Mind Medicine Institute. Mind Medicine Australia is focused specifically on the clinical application of regulatory approved medicinal psilocybin and medicinal MDMA assisted therapies for certain mental illnesses; its focus is entirely clinical in nature.
“PharmAla is currently the only company in North America which has completed a full GMP value chain for MDMA. We’re so excited to be able to advance the work of Mind Medicine Australia, an organization which I have long admired for both their scientific rigour and advocacy efforts,” said Nick Kadysh, PharmAla’s CEO. “I know that these research materials will be put to good use, healing people and generating the data which Mind Medicine will use in their continuing efforts to legalize and destigmatize MDMA and other psychedelic-based treatments.”
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
