Psyched: Musk's Empathy Tweets, Psychedelics In Congress, Oregon's Opt-Outs, MAPS' MDMA Trial And More

Elon Musk Joins Twitter Conversation Around Psychedelics: A Debate On Empathy

Elon Musk continues touting the benefits of psychedelics, from his live interview at CodeCon2021 to his most recent tweets endorsing those working towards developing these substances for better therapeutic effects and even revisiting his own experience with them.

Tesla TSLA’s CEO aligned with OpenAI CEO Sam Altman who said on Sunday in a Twitter thread that “a lot of crazy stories start with too many amphetamines and end with not enough psychedelics,” which triggered a response from Musk.

“Amphetamines negatively affect empathy, psychedelics do the opposite,” said Twitter’s new owner and CEO. While the comment might not be surprising in view of his previous remarks in favor of psychedelics, it is meaningful as it draws attention to a somewhat overlooked topic.

Psychedelic experiences have been linked to increases in emotional empathy. Studies found that psilocybin increased empathy and creativity after a trip and further on for up to seven days while LSD acutely reduced fear recognition and enhanced emotional empathy and sociality.

Continue reading HERE.

Congress: New Bipartisan Psychedelics Caucus And ‘Breakthrough Therapies Act’ Introduced 

Psychedelics have made it to Capitol Hill with the creation of a Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus. 

Led by Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), the caucus will consist of bipartisan members of Congress committed to “addressing 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 the congressional talks on psychedelics as potential therapeutics as well as establish itself as a public educational resource.

The caucus recognizes federal agencies, including those under the National Institutes of Health (NIH), have already put funding toward exploring the therapeutic potential of psychedelics and intends to support those efforts while promoting the generation of “enough safety and efficacy (clinical) data” for the FDA and DEA to decide on the future of PAT.

Continue reading about 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 requesting the DEA move psychedelic “breakthrough therapies” like psilocybin and MDMA from Schedule I to Schedule II, as reported Marijuana Moment. 

The two measures are closely aligned, as the Senate bill demands removing research barriers for controlled substances, which includes psychedelics, while the caucus was created to promote the advancement of new treatments derived from these substances.

Booker and Paul's legislation proposes to amend the Controlled Substances Act (CSA) in such a way that current and future drugs designated as “breakthrough therapies” by the FDA, or qualify for a waiver under the Food, Drug and Cosmetic Act and be moved to Schedule II. 

The new classification would still tightly restrict the use of these drugs to the medical field, yet would facilitate research and development.

Continue reading on the “Breakthrough Therapies Act” HERE.

Oregon's Opt-Out Results & Future Unfolding Of Psilocybin Service Centers

In the November midterms, many Oregonians decided to vote against the establishment of psychedelic-assisted therapy centers in their localities.

Several cities and counties had expressed their decision to opt out of the Psilocybin Services Act, a possibility included within the 2020 statewide measure. The ballot reflected the rural-urban divide as 27 out of 36 Oregon counties and 115 towns called on their voters to decide whether to allow the therapeutic centers to function in their territories.

Psychedelic Alpha’s tracker shows opt-outs passed in almost two-thirds of the state, yet the cities with the largest populations opted in. including Portland and most of the Willamette Valley.

Only two towns -Phoenix and Wheeler and Deschutes and Jackson counties voted to ban the measure whereas 25 counties opt-out won. Four counties -Clackamas, Clatsop, Curry and Tillamook- switched from being in favor of Measure 109 to being against it. 

This translates to unincorporated areas within those counties where psilocybin centers and manufacturing will remain illegal. Noticeably, 17 of the total 137 opt outs will only last two years, and the remaining prohibitions can be terminated if voters decide so. 

Nine counties did not include opt-outs in their ballots and therefore automatically registered into the program: Benton, Columbia, Lincoln, Lane, Hood River, Multnomah, Wasco, Yamhill and Washington. 

Local governments are still assessing time, place and manner (TPM) regulations, and will most likely not promulgate specific land use and zoning for psilocybin centers before the Oregon Health Authority (OHA) presents its set of rules by the end of 2022.

Nonetheless, these businesses must present a local Land Use Compatibility Statement (LUCS) in order to get their license from the OHA. So it is yet to be seen how localities will regulate in the period spanning between the start of the license applications in Jan. 2023, and the wrap-up of local TPM rules.

Learn more on the results, the upcoming implementation process, and what advocates are saying HERE. 

MAPS Completes Second Phase 3 Trial Of MDMA-Assisted Therapy For PTSD, Topline Data & New Drug Application Next

MAPS Public Benefit Corporation (PBC) announced the final participant’s last Evaluation and Exit Planning therapeutic session was completed 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 commercializing prescription psychedelics following a public benefit focus.

The clinical trials 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 had a clinically significant improvement in their PTSD symptoms, and 67% no longer qualified for a PTSD diagnosis.

Now, a blinded interim analysis of MAPP2 results conducted by an independent Data Monitoring Committee stated that, as of May 2022, the trial had a sufficient number of participants to statistically detect the efficacy of MDMA-assisted therapy for PTSD.

“The completion of data gathering in our second Phase 3 study of MDMA-assisted therapy for PTSD is a critical milestone in MAPS’ 36-year campaign to obtain FDA approval for the therapeutic use of MDMA. I’m proud of our team of therapists, staff, donors, funders, and especially the brave patients who volunteered to confront their trauma in our studies” said Rick Doblin, Ph.D., MAPS executive director. 

The Milestone Round

Each week, we learn about new clinical trials, the creation of psychedelic-based compounds and novel potential treatments for those suffering from mental and physical health conditions.

This time of the year represents closing of quarters for most psychedelics companies. Following last week’s trend, the turn came for Reunion Neuroscience REUN, Mydecine MYCOF, Cybin CYBN, Biomind Labs BMNDF to share their financial results and business outcomes. 

Some partnership announcements were made as well, most noticeably Mindset Pharma MSSTF and PharmAla Biotech’s exclusive sales deal for cGMP psilocybin, and Revitalist RVLWF and startup WAKE Network’s joint venture for vertical psychedelic clinics and retreats.

As for clinical trials, Beckley completed its Phase 1 trial on the proprietary 5-MeO-DMT drug for TRD, Wellbeing KONEF’s KGK is advancing negotiations for a Phase 2 trial on psilocybin microdoses for FXS symptoms, and Algernon AGNPF is about to begin a Phase 1 study on its DMT compound for human stroke treatments.

A thorough coverage of the academic publication of COMPASS Pathways CMPS’ Phase IIb clinical trials of psilocybin for TRD is being served as a four-part series, the first being an overview of the trials’ outcomes, and the second assessing some of the comments it brought about.   

Miscellaneous news includes Field Trip’s new year-round psychedelic-assisted therapy treatment protocol offer, Clearmind CMND’s listing on NASDAQ with an initial public offering pricing of up to $7.5M, and some more political news concerning the potential inclusion of a psychedelics decriminalization bill in Illinois. 

Psychedelics EFTs Weekly Performance

This is how the sector’s major EFTs performed in the week spanning November 14 to 18.

• AdvisorShares Psychedelics PSIL opened Monday, Nov. 14 at $2.45, higher than the prior week’s opening at $2.33 but still nowhere near Oct. 10’s opening at $2.80. That price fell during the whole week up to the lowest $2.33, achieved on Thursday 17 and the closing price for Friday 18. Still, it is higher than the prior week’s lowest at $2.26. This week was actually similar to Oct. 31-Nov. 4 when the highest point was $2.47, and lowest was $2.38. 

The Elemental Advisors PSYK EFT PSYK opened Monday, Nov. 14 at $18.02, substantially higher than the prior week’s opening at $17.05, Monday, Oct. 31’s opening at $17.62, Monday, Oct. 24’s opening at $16.97, and close to Monday, Oct. 10’s $18.40. After that, price fell all the way down to the week’s lowest at $17.52 on Thursday 17, also higher than former week’s lowest $17.13. Nonetheless, the closing price was $17.88, which is lower than Friday 11’s closing at $18.19.
For this EFT, the yearly price range is set between $23.32 and $16.71.