Psyched: Musk’s empathy tweets, psychedelics in Congress, Oregon denial, MAPS MDMA trial, and more. – Biomind Labs (OTC: BMNDF), Algernon Pharmaceuticals (OTC: AGNPF)
Elon Musk Joins the Twitter Conversation Around Psychedelics: A Debate on Empathy
Elon Musk continues touting the benefits of psychedelicsfrom his live interview at CodeCon2021 to his most recent tweets endorsing those working to develop these substances for better therapeutic effects and even review his own experience with them.
You’re here TSLACEO of aligned with Sam Altman, CEO of OpenAI who said sunday in a Twitter feed that “a lot of crazy stories start with too many amphetamines and end with not enough psychedelics,” prompting a response from Musk.
“Amphetamines negatively affect empathy, psychedelics do the opposite,” said the new owner and CEO of Twitter. While the comment isn’t surprising given his earlier remarks in favor of psychedelics, it’s significant because it draws attention to a somewhat overlooked topic.
Psychedelic experiences have been related to increases of emotional empathy. Studies have revealed that psilocybin increased empathy and creativity after travel and further up to seven days while LSD greatly reduced fear recognition and improved emotional empathy and sociality.
continue reading HERE.
Congress: Presentation of a new bipartisan caucus on psychedelics and a “breakthrough therapy law”
Psychedelics came to Capitol Hill with the creation of a Congressional Advancing Clinical Treatments (PACT) caucus on psychedelics.
Directed by Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), the caucus will be made up of bipartisan members of Congress committed to “finding ways to alleviate the national mental health crisis through psychedelic science and research.”
The caucus will not promote or offer recommendations on decriminalization or legalization measures, but rather lead congressional talks on psychedelics as a potential therapy as well as establishing itself as a public educational resource.
The caucus recognizes federal agencies, including those under the National Institutes of Health (NIH), have already invested in exploration the therapeutic potential of psychedelics and intends to support these efforts while promoting the generation of “sufficient (clinical) data on safety and efficacy” for the FDA and DEA decide on the future of the PAT.
Keep reading on the new caucus HERE.
Thursday was also an important day for psychedelics on Capitol Hill as Senators Cory Booker (D-NJ) and Rand Paul (R-KY) jointly filed a bill calling for the DEA displacing psychedelic “breakthrough therapies” like psilocybin and MDMA from Annex I to Annex IIas reported Marijuana time.
The two measures are closely aligned, since the Senate bill demands the removal of barriers to research on controlled substances, including psychedelicswhile the caucus was created to promote the advancement of new treatments derived from these substances.
Booker and Paul’s legislation proposes to change the Controlled Substances Act (CSA) so that current and future drugs designated as “breakthrough therapies” by the FDA, or benefit from an exemption under the Food, Drug and Cosmetics Act and be moved to Appendix II.
The new classification would still narrowly limit the use of these drugs to the medical field, while facilitating research and development.
Keep reading on the “Breakthrough Therapies Act” HERE.
Oregon opt-out results and future development of psilocybin service centers
Mid-term in November, many Oregonians decided to vote against the creation of psychedelic-assisted therapy centers in their localities.
Several cities and counties had expressed their decision to withdraw from the law on psilocybin services, a possibility included in the 2020 Statewide Measure. The poll reflected rural-urban divide while 27 of Oregon’s 36 counties and 115 cities called on their voters to decide whether to allow therapy centers to operate in their jurisdictions.
Psychedelic Alpha tracker shows opt-outs passed in nearly two-thirds of the statebut the most populous cities opted in, including Portland and most of the Willamette Valley.
Only two cities – Phoenix and Wheeler and Deschutes and Jackson counties voted to ban the measure while 25 counties opted out. Four counties – Clackamas, Clatsop, Curry and Tillamook – went from supporting Measure 109 to unfavorable.
This results in unincorporated areas in these counties where psilocybin centers and manufacturing will remain illegal.. Notably, 17 of the total 137 opt-outs will only last two years, and the remaining bans can be lifted if voters choose.
Nine counties did not include opt-out options on their ballots and therefore automatically signed up for the program: Benton, Columbia, Lincoln, Lane, Hood River, Multnomah, Wasco, Yamhill and Washington.
Local governments always evaluate time, place and manner (TPM) regulationsand most likely will not enact specific land use and zoning for psilocybin centers until the Oregon Health Authority (OHA) presents its set of rules by the end of 2022.
However, these businesses must submit a local Land Use Compatibility Statement (LUCS) in order to obtain their license from the OHA.. It therefore remains to be seen how localities will regulate during the period between the start of license applications in January 2023 and the conclusion of local MPT rules.
Learn about the results, the upcoming implementation process, and what advocates are saying HERE.
MAPS Completes Second Phase 3 Trial of MDMA-Assisted Therapy for PTSD, Key Data and New Drug Application
MAPS Public Benefit Corporation (PBC) announced that the last participant’s final therapy assessment and discharge planning session ended in MAPP2, a multi-site phase 3 study of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD).
A wholly-owned subsidiary of the renowned Multidisciplinary Association for Psychedelic Studies, MAPS PBC was founded in 2014 as a non-profit organization with the goal of developing and marketing prescription psychedelics for the public good.
The clinical trial program for MDMA-Assisted Therapy (MDMA-AT) for PTSD has been sponsored by MAPS since 2000 and administered by MAPS PBC since 2014.
The results of the first phase 3 trial were statistically significant, with a large effect size and a favorable safety profile. Specifically, MAPP1 proved that 88% of participants who received MDMA-assisted therapy experienced clinically significant improvement in their PTSD symptomsand 67% are no longer qualified for a diagnosis of PTSD.
Now, a blinded interim analysis of MAPP2 results conducted by an independent data monitoring board said that in May 2022, the trial had a sufficient number of participants to statistically detect the effectiveness of MDMA-assisted therapy for PTSD.
“The completion of data collection in our second Phase 3 study of MDMA-assisted therapy for PTSD is a critical milestone in MAPS’ 36-year campaign to gain FDA approval for the use MDMA therapy. I am proud of our team of therapists, our staff, our donors, our funders and especially the brave patients who have volunteered to face their trauma in our studies,” said Rick Doblin, Ph.D., Executive Director of MAPS.
The round of milestones
Every week we learn about new clinical trials, the creation of psychedelic-based compounds, and potential new treatments for people with mental and physical health issues.
This time of year is end of quarters for most psychedelic companies. Following last week’s trend, the turn has come for The Neuroscience Meeting REUN, Mydecine MYCOF, Cybin CYBN, Biomind Laboratories BMNDF to share their financial and business results.
Some partnership announcements have also been made, including Mindset Pharma MSSTF and PharmAla Biotech exclusive sales agreement for cGMP psilocybinand revitalist RVLWF and the startup WAKE Network’s joint venture for vertical psychedelic clinics and retreats.
As for clinical tests, Beckley has completed his phase 1 trial on the proprietary drug 5-MeO-DMT for TRD, Welfare KONEFit is KGK advances negotiations for a Phase 2 trial of psilocybin microdoses for FXS symptomsand Algiersnon AGNPF is about to start a Phase 1 study of its compound DMT for the treatment of human strokes.
Full coverage of the academic publication of COMPASS Pathways CMPS‘ Phase IIb Clinical Trials of Psilocybin for TRD is served as a four-part series, the first being a overview of test resultsand the second evaluating some of the comments it has elicited.
Miscellaneous news includes what’s new from Field Trip year round psychedelic assisted therapy treatment protocol to offer, clear mind CMNDis listed on NASDAQ with an initial public offering price of up to $7.5 million, and some new policies regarding the potential inclusion of bill to decriminalize psychedelics in Illinois.
Weekly Performances of Psychedelic EFTs
This is how the major ETFs in the sector fared during the week of November 14-18.
AdvisorShares Psychedelics PSIL open monday, November 14 at $2.45, higher than the previous week’s open at $2.33 but still far from the October 10 open at $2.80. This price fell throughout the week until lowest $2.33performed on Thursday 17 and Friday 18 closing price. Still, it is above the previous week’s low at $2.26. This week was actually similar to October 31-November. 4 when the highest point was $2.47 and the lowest was $2.38.
Elemental Counselors PSYK EFT PSYK open monday, November 14 at $18.02, significantly higher than the previous week’s open at $17.05, Monday October 31 open at $17.62, Monday October 24 open at $16.97 and Monday October 10 close at 18.40 $. After that, the price fell to the low of the week at $17.52 on Thursday the 17th, also higher than the previous week’s low of $17.13. Nevertheless, the the closing price was $17.88, which is lower than the Friday 11th close of $18.19.
For this EFT, the the annual price range is set between $23.32 and $16.71.