You are currently viewing Pα+ Psychedelic Bulletin #180: Mass. Psychedelics Ballot Post-Mortem Begins; Cybin Commences Phase 3; CaaMTech Claims It’s Solved Functional Unblinding

Pα+ Psychedelic Bulletin #180: Mass. Psychedelics Ballot Post-Mortem Begins; Cybin Commences Phase 3; CaaMTech Claims It’s Solved Functional Unblinding

In this Issue

  • Massachusetts’ Psychedelics Ballot Question Post-Mortem Begins
  • Cybin Commences Phase 3 Program of Deuterated Psilocin, CYB003, in Major Depressive Disorder
  • Opt-Out Trend Continues: Oregon’s Local Jurisdictions Push Back on Psilocybin Access
  • CaaMTech Claims It’s Solved Functional Unblinding, But Won’t Tell Us How
  • Compass Says Phase 3 Readout Punt Is About Durability, Not Unblinding
  • Lykos-Funded Study Finds MDMA-AT Cost Effective with Drug Priced at $12k per Session
  • Other Stories including: RFK Jr. Scores HHS Position; UC Davis Researchers Claim Separation of DOI’s Hallucinogenic and Anxiolytic Effects; Relmada Launches Ph 1 Study of Low-Dose Psilocybin; Numinus Sells Clinics; and more.

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Massachusetts’ Psychedelics Ballot Question Post-Mortem Begins

Last-minute donations from Dr. Bronner’s ($100k), Elliot Cohen ($100k), Eliza Dushku ($100k), MAPS ($50k), and others could not push Question 4 over the line, with the Massachusetts ballot initiative suffering defeat by a convincing margin. (See Question 4 Fails: Massachusetts Says No to State-Regulated Psychedelics Access and Decriminalisation.)

The Yes campaign, organised under Massachusetts for Mental Health Options (MMHO), hosted a results party on election night, but the event was decidedly private, with our assigned reporter on the ground hoofed out of the do. (He wasn’t the only journalist to suffer that fate, with Boston’s local NPR outlet’s reporter shown the door, too!)

Now, the post-mortem has begun.

Sam Chapman, who is currently the Policy and Development Director at the Microdosing Collective but previously led on the development and roll-out of state-level psychedelic programs at Healing Advocacy Fund, believes the ballot question was too complex.

“​​With Question 4, the title had to cover decriminalization, home cultivation, personal possession, and a regulated program—all complex issues bundled together”, Chapman told us. “This broad scope may have contributed to voter hesitation”, he added, suggesting that future attempts should have “ballot titles that clearly convey the intent without overwhelming voters.”

Indeed, we had heard this from those on the ground in Massachusetts throughout the campaign, and mentioned it several times in our own commentary.

MAPS’ Rick Doblin believes that the failure in Massachusetts can be partially attributed to a broader public narrative shift around psychedelics, one that’s gone “from hope to caution”. Echoing sentiments expressed during Lykos Therapeutics’ new drug application review process, Doblin told us that he believes the company “lost control over the public narrative”, with the FDA rejection and associated negative press “further diminishing public confidence and support.” He was also keen to point out Compass Pathways’ recent layoffs and Phase 3 readout delay as another example of a challenging time for the field.​​

The results in Mass. “suggest it will be four years or more” before another initiative goes before Bay Staters, Doblin said, urging proponents to focus on more public education and to be hopeful for promising data out of Oregon and Colorado’s programs.

Others have accused New Approach PAC of failing to engage sufficiently with grassroots groups or to reach local people, with many voters unaware of the question’s existence until they were confronted with it on the ballot.

For its part, New Approach looks keen to shift blame onto those very grassroots groups. “We understand there were concerns about the home grow provisions, and those concerns likely led to tonight’s result,” it said in immediate response to the results. Those home grow provisions, of course, were of tantamount importance to many grassroots psychedelics groups in the state.

Will this experience lead New Approach to reevaluate its strategy, or will it encourage it to push ahead with a more top-down approach to state-by-state psychedelic drug policy reform? More to come.

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Cybin Commences Phase 3 Program of Deuterated Psilocin, CYB003, in Major Depressive Disorder

Cybin has become the latest drug developer to take a psychedelic into Phase 3, with its Wednesday announcement that its PARADIGM program has commenced.

The program consists of two Phase 3 (APPROACH and EMBRACE) as well as an open-label extension study (EXTEND) that takes over after week 12 in both of the core studies. Each of the trials will evaluate the company’s deuterated psilocin candidate, CYB003, in patients with moderate to severe major depressive disorder (MDD; MADRS scores ≥24) who are on a stable dose of antidepressants but are not responding sufficiently.

CEO Doug Drysdale characterised the FDA review process as “highly collaborative and thorough”, and described several design features that he hopes will assuage the agency’s concerns and prove out the potential scalability of CYB003 in MDD. Those include…

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