This Week:
- 💊 Delix’s Non-Hallucinogenic Candidate Enters the Clinic
- 🗽 American Psychiatric Association Survey Polls U.S. Adults on Psychedelic Treatments
- 🌵 Arizona Earmarks $5m for Whole Mushroom Psilocybin Trials
- 🏛 Members of the European Parliament Form Medical Psychedelics Action Group
- 💵 NIDA Commits $1.5m to Psychedelics for Addiction Research
- 💂 UK’s International Recognition Regime Takes Shape
- ⚖️ Psychedelic Policy Reform Updates
and lots more…
Psychedelic Sector News
Delix’s Non-Hallucinogenic Candidate Enters the Clinic
Earlier this month, Boston-based drug developer Delix Therapeutics announced that a Phase 1 study of its DLX-001 candidate has commenced.
The trial will seek to enrol around 100 healthy volunteers at the Centre for Human Drug Research in the Netherlands.
As we have covered previously, Delix is hoping that its non-hallucinogenic compounds will maintain some of the apparent therapeutic properties of psychedelics while skipping the trip. Ultimately, the company would hope for their drug candidates to prove safe enough to be dispensed as take-home prescriptions. See Skipping the Trip: Non-Hallucinogenic Psychedelics for more.
This is the first time one of Delix’s candidates is being tested in humans. “We do not know how high we will have to escalate the doses”, Delix’s Head of Research and Development Eliseo Salinas told Psychedelic Alpha.
Results are expected in Q1 2024.
American Psychiatric Association Survey Polls U.S. Adults on Psychedelic Treatments
The American Psychiatric Association (APA) has been running its Healthy Minds Monthly opinion polls since late 2021, and an annual poll since 2017, aiming to track timely mental health issues.
Interestingly, the association’s most recent poll asked several questions about “mental health treatments involving previously [sic] banned substances, such as cannabis, psychedelics, and ketamine.”
According to the poll, half of U.S. adults were familiar with these treatments, with younger respondents more likely to be aware of them. While half of adults said they would be likely to consider a mental health treatment that involves cannabis, a majority expressed being unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).
On the flip side, we might infer that 41% of U.S. adults would consider a mental health treatment involving psychedelics: no small statistic!
And, the fact that APA included this question at all is quite significant.
Arizona Earmarks $5m for Whole Mushroom Psilocybin Trials
Arizona’s state budget for FY2024 includes a competitive grant program that will award $5m to researchers looking to conduct clinical trials with “whole mushroom psilocybin”.
The trials can be targeted toward treating any of thirteen conditions, ranging from PTSD and depression through to Long Covid symptoms and inflammatory disorders. Trials funded by the carve-out should prioritise using “whole mushroom psilocybin cultivated under a schedule I license”; and enrolling “veterans, first responders, frontline health care workers and persons from underserved communities as the research subjects.”
Dr. Sue Sisley, MD, who has long been campaigning for trials into whole psilocybin mushrooms, as opposed to synthetic psilocybin, played a key role in advancing this grant funding.
Featured Psychedelic Jobs
- Head of Research at Lionheart Ventures.
- Postdoc Research Associate at University of Utah College of Social Work Center on Mindfulness and Integrative Health Intervention Development.
Browse more roles and get more job posts to your inbox by signing up for alerts here. Make an account to join our free talent pool, too.
Miscellaneous News
Members of the European Parliament Form Medical Psychedelics Action Group
Just over a half-dozen Members of the European Parliament (MEPs) have established the MEP Action Group for the Medical Use of Psychedelics, with the assistance of PAREA and PsychedelicsEurope.
The group hopes to steer “the institutional discussions on the therapeutic application of psychedelics”, according to MEP Sara Cerdas (Portugal, S&D).
Given the fact that the European Commission is gearing up to reveal its mental health strategy, the Action Group will hope this is an opportune time to provide input to EU initiatives.
NIDA Commits $1.5m to Psychedelics for Addiction Research
Via three Notice of Funding Opportunities posted earlier this month, NIDA has announced its earmarking of $1.5m for “advancing psychedelics research for treating addiction”.
Projects are sought for non-clinical trials, clinical trials and basic experimental study with humans.
UK’s International Recognition Regime Takes Shape
As we covered in Bulletins #131 and #133, the UK is looking to make its drug approvals process ‘faster and nimbler’ as it struggles to find its post-Brexit bearings.
Part of this strategy (or, new reality) was expected to be an enhanced regulatory recognition framework that would aim to accelerate access to treatments that were approved by “trusted international agencies”.
The original release from the Government mentioned the US, Japan and Europe, but new details reveal a broader suite of regulatory recognition routes than many expected. These include:
- Australia
- Canada
- the European Union
- Japan
- Switzerland
- Singapore
- U.S.
It’s worth noting that the UK already had similar programs in place with these countries through other projects, such as the cancer drug focused Project Orbis and, perhaps most notably, the Access Consortium.
The framework should be in place by Q1 2024, meaning MDMA-assisted therapy might be among the first treatments considered under the program.
Media Clippings
The Guardian | Using psychedelics for depression is exciting area, says ex-vaccines chief. (May 28)
“Kate Bingham, who chaired UK’s Covid vaccine taskforce, tells Hay festival she hopes mind-altering drugs could treat mental illness” (May 29)
POLITICO | K Street warms up to psychedelics. POLITICO surveys some of the pro-psychedelic reform lobbying efforts underway in the U.S. (May 26)
Association of American Medical Colleges | Can psychedelic drugs, once banned, help relieve mental illness? “Decades after most hallucinogens were outlawed as dangerous, researchers are using them to treat disorders like PTSD, depression, and addiction. Still a mystery: How they actually work.” (May 18)
The Guardian (podcast) | Will psychedelic drugs transform mental health treatment? (May 9)
TechCrunch+ | 11 investors predict a colorful, if difficult, future for psychedelic startups. TechCrunch+ speaks with seven VCs about the future of psychedelic business. (May 12)
UK Parliament | MPs debate access to psilocybin treatments. Transcript and Research Briefing (18 May)
Psychedelic Alpha | Our live-tweet thread of COMPASS Pathways’ Q1 2023 earnings call (May 11)
APA | The power of science communication: 5 questions for Heather Berlin. “Psychedelic psychotherapy is going to change things a lot. I’ve seen it with my own patients, where nothing else has worked” (May 3)
Deadline | Lucy Walker Directing Ibogaine Feature Doc ‘Of Night & Light’, Lands Secret Tribeca Slot (May 10)
Women’s Health | Is psychedelic therapy the next-gen treatment we think? (May 11)
Psychedelic Policy Reform Updates
The below updates are more granular than those in our Psychedelic Legalization & Decriminalization Tracker, which is produced with the support of experts at Calyx Law and Emerge Law Group.
These updates reflect the period May 6th to 29th, 2023.
SB 242 – Nevada
Requires the Department of Health and Human Services to establish the Psychedelic Medicines Working Group
Introduced: March 9, 2023
Latest Action Date: May 29, 2023
Latest Action: Passed by committee
Next Action: Advance for further floor action in the Senate
On May 29, 2023, the Committee on Finance recommended SB 242 pass as amended after being passed by the Committee on Health and Human Services in April. The bill will now advance for further floor action in the Senate, its house of origin. If enacted, the bill would require Nevada’s Department of Health and Human Services to “establish the Psychedelic Medicines Working Group to study certain issues relating to the therapeutic use of entheogens”.
H 3605 – Massachusetts
An Act concerning the legal use of the plant medicine known as psilocybin for therapeutic, spiritual, and medicinal purposes
Introduced: March 30, 2023
Latest Action Date: May 26, 2023
Latest Action: Referred to Committee on Public Health
Next Action: Hearing scheduled for June 6, 2023
On March 30, 2023, Massachusetts bill H 3605 was referred to the committee of Public Health. A hearing for the bill has since been scheduled for June 6, 2023. The bill, if passed, would see the Department of Public Health establish procedures “for the granting of psilocybin facilitator licences.”
H 3574 – Massachusetts
An Act concerning the use of a prescription medicine that contains 3,4-methylenedioxymethamphetamine (MDMA)
Introduced: March 3, 2023
Latest Action Date: May 26, 2023
Latest Action: Senate concurred
Next Action: Hearing scheduled for June 6, 2023
On March 30, 2023, bill H 3574 was introduced in Massachusetts. This bill, which seeks to establish a maximum treatment cost of $5,000 for MDMA-assisted therapy, was referred to the committees on Elder Affairs and Public Health. On May 26, 2023, a hearing was scheduled for the bill which is slated to take place on June 6, 2023.
SB 806 – Rhode Island
An Act Relating to Food and Drugs
Introduced: March 23, 2023
Latest Action Date: May 26, 2023
Latest Action: Hearing scheduled for June 1, 2023
Next Action: Hearing to take place
On March 23, 2023, SB 806 was introduced in Rhode Island and referred to the Senate Judiciary. On May 26, 2023 a hearing was scheduled for SB 806 which is to take place on June 1, 2023. This bill, if passed, would amend the “law on controlled substances to permit a person to possess less than 1 ounce of psilocybin and would allow psilocybin to be cultivated at a person’s residence for personal use.”
SB 303 – Oregon
Relating to psilocybin services; and prescribing an effective date.
Introduced: January 9, 2023
Latest Action Date: May 26, 2023
Latest Action: Signed by Senate President and Speaker of the House
Next Action: To be signed by Secretary of Senate
On May 23, 2023 Oregon’s SB 303 passed its third reading in the house. The bill, which has now passed both houses, has been signed by the Senate President and the Speaker of the House. SB 303 must now be signed by the Secretary of the Senate before it is sent to Oregon’s Governor where it can be signed into law. If passed into law, SB 303 would require psilocybin service centres and facilitators to collect and report data on client details, adverse events, and other related information.
SB 58 – California
Controlled substances: decriminalization of certain hallucinogenic substances.
Introduced: December 16, 2022
Latest Action Date: May 25, 2023
Latest Action: In Assembly, First Reading
Next Action: Assembly vote
On May 24, 2023, California’s SB 58 was read for the third time. The bill was passed with 21 votes in favour and 16 votes in opposition. SB 58 was subsequently ordered to the Assembly where its first reading took place on May 25, 2023. The bill must now pass a vote in the Assembly before moving forward in the legislative process. If enacted, SB 58 would, amongst other things, “make lawful the possession, preparation, obtaining, transfer, as specified, or transportation of, specified quantities of psilocybin, psilocyn, dimethyltryptamine (DMT) , ibogaine, and mescaline, for personal use or facilitated or supported use, as defined, by and with persons 21 years of age or older.”
SB 23-290 – Colorado
Natural Medicine Regulation And Legalization
Introduced: April 18, 2023
Latest Action Date: May 23, 2023
Latest Action: Governor Signed
On May 2, 2023, Colorado’s Senate concurred with amendments made to SB 23-290 by the House. The bill was subsequently signed by the Speaker of the House and President of the Senate before being sent to Colorado’s Governor. On May 23, 2023 Governor Jared Polis signed SB 23-290 which clarifies and modifies parts of Colorado’s Natural Medicine Health Act which was passed in November 2022.
LD 1914 – Maine
An Act To Enact The Maine Psilocybin Health Access Act
Introduced: May 9, 2023
Latest Action Date: May 22, 2023
Latest Action: Word session held, bill tabled
On May 9, 2023, LD 1914 was introduced in Maine. The bill, which seeks to “enact the Maine Psilocybin Health Access Act”, was then referred to the Committee on Veterans and Legal Affairs. Following a work session which was held on May 22, 2023, LD 1914 was delayed.
HB 727 – North Carolina
Breakthrough Therapies Research/Advisory Act.
Introduced: April 18, 2023
Latest Action Date: May 16, 2023
Latest Action: Referred to Committee on Appropriations
Next Action: Referral to Committee on Rules, Calendar, and Operations
On April 18, 2023, HB 727 was introduced in North Carolina. After passing its first reading on April 19th, the bill was referred to the House Committee on Health. The bill was subsequently referred to the committee on Appropriations on May 16, 2023. If reported favourably, HB 727 will advance to the Committee on Rules, Calendar, and Operations before proceeding through the early steps in the legislative process. If eventually signed into law, HB 727 would establish a Breakthrough Therapies Research Grant Fund that would provide two $2.5m grants to North Carolina research projects investigating the use of MDMA or Psilocybin to treat certain psychiatric indications in qualifying patient populations.
HB 6734 – Connecticut
An act concerning the decriminalization of possession of small amounts of psilocybin
Introduced: February 22, 2023
Latest Action Date: May 12, 2023
Latest Action: Assigned Senate Calendar Number
Next Action: Senate vote
On May 10, 2023, after passing through the House, HB 6734 was tabled for the Calendar in the Senate. HB 6734 will now be debated and amendments to the bill can be proposed before a final Senate vote occurs. Should amendments be made, the bill will need to return to the first chamber for a subsequent vote. Should HB 6734 eventually be signed into law, criminal penalties for possession of up to one-half ounce of psilocybin would be eliminated.
SB 5263 – Washington
Concerning access to psilocybin services by individuals 21 years of age and older.
Introduced: January 11, 2023
Latest Action Date: May 9, 2023
Latest Action: Partially vetoed and signed by Governor
On April 20, 2023, Washington’s SB 5263 was delivered to the state’s governor after being accepted by both the House and Senate. SB 5263, when introduced, sought to regulate psilocybin services for individuals over the age of 21 in the state. However, SB 5263 underwent some significant changes after a Senate committee approved a substitute bill which narrowed the bill’s original scope in late February 2023. On May 9, 2023 Washington’s governor signed the substitute to SB 5263. However, the governor vetoed sections 1, 2, 3, 4, 5, 6, 10, and 11 of the bill. These sections would have seen the establishment of a psilocybin advisory board and an interagency working group between the aforementioned advisory board and the Department of Health, Department of Agriculture, and the Liquor and Cannabis Board. However, the governor stated that the “advisory board’s role is unclear” given that a similar task force, established last year, “has yet to complete its work.”
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