A weekly round-up of the
latest coverage in psychedelics.
Receive the free weekly digest straight to your inbox every week
By signing up, you agree to our privacy policy. You can unsubscribe at any time.
March 25 – 31, 2024
ICER Draft Evidence Report on Lykos’ MDMA-Assisted Psychotherapy Deems Clinical Evidence “Insufficient”
Psychedelic Alpha ↗
We review ICER’s draft evidence report on Lykos Therapeutics’ MDMA-AP, which finds that the publicly-available clinical evidence on the intervention is “insufficient” to inform a comparative clinical effectiveness analysis. The report also highlights clinical and ethical concerns surrounding the studies.
Special Issue on Psychedelic Therapy: A Primer for Primary Care Clinicians (Mar/Apr)
American Journal of Therapeutics ↗
atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression
Press Release ↗
According to the press release, a single dose of BPL-003 “demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12”.
It’s worth noting that the initial topline results represent 12 participants.
Beckley Psytech also published its own press release.
Psychedelics Design Conference (April 11, Virtual)
Psychedelics Design ↗
Tickets are priced at £20 / $25. Get 15% off, using code PsychedelicAlphaPD15 here.
March 18 – 24, 2024
This week’s feed is sponsored by
DISCOVERY SESSIONS 2024
Discovery Sessions brings together thought leaders at the forefront of psychedelics across culture, policy, science, and conscious entrepreneurship to engage in a spirited, inclusive dialogue to envision a brighter future.
April 18-19, San Francisco
More info + tickets
Usona Institute Announces Launch of uAspire Phase 3 Clinical Trial Investigating Psilocybin for Major Depressive Disorder
Press Release ↗
Visit ClinicalTrials.gov for more information on the protocol (NCT06308653).
Fluence’s Elizabeth Nielson on Professional Education for the Psychedelics Field
Psychedelic Alpha ↗
Magic and Medicinal: On the Pharmacological Potential of Mushrooms
Literary Hub ↗
An excerpt from Molds, Mushrooms, and Medicines: Our Lifelong Relationship with Fungi by Nicholas P. Money.
VA Portland Health Care opens first-of-its-kind psychedelic medicine research center
Portland Business Journal ↗
The psychedelic AI found
POLITICO ↗
POLITICO covers Mindstate Design Labs’ IND submission for a Phase I study of 5-MeO-MiPT.
Ibogaine, the psychedelic, unlikely to receive approval as opioid treatment, says top addiction researcher
STAT ↗
“The remarks from Nora Volkow, the longtime director of the National Institute on Drug Abuse, serve as a cautionary note amid widespread enthusiasm about ibogaine, a naturally occurring substance that drug companies and researchers have increasingly cast as a potential paradigm-shifting addiction treatment.”
March 11 – 17, 2024
U.S. Psychedelic Legalization & Decriminalization Tracker (Updated March 14th)
Psychedelic Alpha ↗
We have been tracking psychedelic policy reform across the United States for a number of years now. Visit the updated map today to see the latest in your state.
Ketamine’s unlikely conversion from rave drug to mental health therapy
New Scientist ↗
New Scientist also produced a video on the topic (15 mins).
After crunching 70k ‘trip reports’, Mindstate looks to test first AI-derived psychedelic on humans
Fierce Biotech ↗
Mindstate has submitted an IND to the FDA to study 5-MeO-MiPT, aka moxy, co-administered with an approved generic. The Phase I trial aims to dose five cohorts of ten healthy volunteers.
Why conservative Missouri lawmakers want to legalize ‘magic mushrooms’ for veterans
Springfield News-Leader ↗
March 4 – 10, 2024
FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder; Company Provides 12-Week Data and Fleshes Out Phase 3 Program Plans
Psychedelic Alpha ↗
Psychedelic drug developer MindMed has announced that the FDA has granted breakthrough therapy designation to its LSD-D-tartrate candidate (MM120) for the treatment of generalised anxiety disorder (GAD). The company also shared topline 12-week data from the same program, as well as results of a pharmacokinetic bridging study and further details on phase 3 study design.
Pα+ subscribers can read our coverage here.
Pα+ Psychedelic Bulletin #158
Psychedelic Alpha ↗
- Fluence and UPRA Team Up to Bring Psychedelic Therapy Training to Ukraine
- MindBio’s Small Open Label Microdosing Study Shows Promise in MDD
- Biomind’s 5-MeO-DMT Study Shows Promise, But Small Sample and Unclear Protocol Temper Excitement
- Oregon Psilocybin Services Complaints
- Further Reading & Other Stories
Prominent At-Home Ketamine Co. Founder, Juan Pablo Cappello, Sounds Alarm, Withdraws Support for the Practice
Psychedelic Alpha ↗
One of the at-home ketamine industry’s biggest boosters has turned bearish, calling for caution among patients and providers and withdrawing his endorsement of the practice. Here, we take a closer look at the case study that changed Cappello’s mind as well as broader concerns around at-home ketamine operators, and we speak with Cappello himself.
atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01
Press Release ↗
Readers might remember that atai shared topline results from a Phase 1 study of the candidate back in October 2023, finding the oral transmucosal film (OTF) formulation to be “well-tolerated with a favorable safety profile”. However, the company announced it would “further optimize” the candidate in preparation for a Phase 2 study in treatment-resistant depression.
As such, this Phase 1b study will compare an improved OTF formulation of the candidate with IV. The improvements include taste masking, a backing layer, “and enhancements to further increase permeability.”
For reference, atai dosed the very first subject with VLS-01 in Q4 2022.
Vancouver to reinstate business licence of illegal magic mushroom dispensary
Vancouver Sun ↗
“At a business licence hearing Tuesday, a three-person panel approved a motion asking staff to reinstate the licence with terms that clarify the business is involved in education and advocacy of medicinal psychoactive substances.”
“We opened the door now, just a crack, but it’s only going to get bigger”, said Dana Larsen.
On March 7th, Vancouver Sun columnist Dan Fumano wrote a piece titled, “Dan Fumano: Psychedelics are illegal — and Vancouver police say criminal charges could be coming”.
CALL FOR SURVEY PARTICIPANTS
↗
Do you have experience conducting psychedelic-assisted therapy outside of the research setting? You may be eligible to participate in a new study from Imperial College London’s Centre for Psychedelic Research. Learn more and participate.
February 26 – March 3, 2024
This Week’s Feed, Sponsored by Odyssey.
Professionally Guided Psilocybin Experiences
Odyssey offers legal, guided psilocybin retreats and individual services based in Oregon. Our experience is modelled after clinical trial protocols and grounded in evidence-based practices. We’re live—book your consultation here.
Book a ConsultationDraft Rules Provide Glimpse at Colorado’s Natural Medicine Market.
↗
As the first set of draft rules for Colorado’s regulated psychedelics market emerge, the folks at Vicente LLP have penned two explainers:
Incannex Announces Positive Topline Results from Phase 2 Psi-GAD1 Clinical Trial of Psilocybin in Generalised Anxiety Disorder
Press Release ↗
The Phase 2a study, which saw 73 GAD patients assigned to receive psilocybin-assisted therapy or placebo with psychotherapy, achieved its primary endpoint.
The sponsor, Incannex, is now preparing to test the intervention in a Phase 2b study. More coverage is available in Bulletin 157.
The study is featured in a new SBS documentary, too.
Separately, Incannex’s Chief Scientific Officer, Mark Bleackley, spoke with Pharmacy Times about psilocybin’s potential.
The therapeutic potential, and addictive lure, of losing yourself
Psyche ↗
In ketamine therapy and other contexts, dissociation is seen as an unwanted side-effect. But what if there’s more to it?
March 1-7, 2024
Pα+
An insider’s guide to the business,
policy and science of psychedelics.
Basic
Free subscribers receive a weekly round-up of news on psychedelics, as well as the occasional article.
Receive regular bulletins, articles, interviews with insiders and quick-take analysis of major stories and developments.
Teams
Teams, groups and corporate pricing plans are available, please get in touch via email to learn more.
Benefits
Front-row access to the psychedelics space: breaking bulletins, in-depth articles, insider interviews and sharp analysis of the moments that matter—from major trial results and funding rounds to policy shifts shaping the future. Plus, full access to our complete archive and Library.
Learn More| Free | ||
|---|---|---|
| Weekly Psychedelic News Feed | ||
| Occasional Articles & Free Resources | ||
| Psychedelic Bulletins (In-Depth Briefings, Multiple per Month) | ||
| Quick-Take Analysis of Major Developments | ||
| In-Depth Articles & Deep Dives | ||
| Exclusive Interviews with Insiders & KOLs | ||
| Quarterly Video Briefings | ||
| Exclusive Tools & Data Resources | ||
| Library of Primers & Explainers | ||
|
Subscribe Now |
||