MAPS Completes Phase III Trial; Bipartisan Senate Bill & Congressional Caucus; UK's NHS Rejects Spravato (again);
Plus updates from Beckley PsyTech and Tactogen
Wow, a lot of positive news from this week to unpack—here’s a glimpse:
MAPS announced the completion of its Phase III trial of MDMA Assisted Therapy for PTSD.
U.S. Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act with an assist from our friends at Reason for Hope.
The Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus was announced by U.S. Reps Lou Correa (D-CA) and Jack Bergman (R-MI) to “focus on exploring psychedelic research to alleviate the U.S. mental health crisis.”
The National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders, announced its “priorities and considerations” for psychedelic research.
For the third time, the U.K.’s National Institute for Health and Care Excellence (NICE) has rejected Spravato for use in the National Healthcare System (NHS), citing high cost and insufficient evidence.
Before we jump in—what do you think—would Elon Musk running the FDA be a good or bad idea?
MAPS Completes Phase III Trial, Sets up FDA Decision
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it completed the second of two Phase III trials of MDMA-AT for the treatment of PTSD.
“MAPS Public Benefit Corporation (MAPS PBC) has announced that the final participant in the second Phase 3 trial of psychedelic-assisted therapy, A Multi-Site Phase 3 Study of MDMA-Assisted Therapy for PTSD (MAPP2), completed their final session in the clinical trial treatment protocol. The clinical trial program for the Breakthrough Therapy has been sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) since 2000 and administered by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, since 2014.”
As noted, this has been a long time in the making, almost 22 years, and marks a significant inflection point for the field as it is the first time that the FDA will be tasked to consider psychotherapy combined with a socially popular, consciousness-altering Schedule I substance in a drug approval decision.
MAPS reports that it plans to complete the submission of the data package to the FDA in the Fall of 2023, setting up a potential approval in 2024.
All indications, including the results of the first Phase III trial and the recent interim analysis of the just-completed second trial, point to positive data.
Assuming all goes to plan and the data supports approval, the decision will come with stipulations beyond the binary thumbs-up or thumbs-down that will affect the cost, access, and commercial rollout.
Most notably, the field will be watching closely for two things:
Approval will likely come with a Risk Evaluation and Mitigation Strategy (REMS), which could include several features that would have a profound impact on costs and accessibility, potentially including requirements for:
Onsite dispensing and administration
Post-treatment observation period
Provider & Site certifications
The Drug Label will be negotiated between MAPS and the FDA and include the final approved indication, which will dictate prescribing practices and reimbursement.
A third component will be rescheduling. Upon FDA approval, the DEA is required by law to reschedule MAPS’ specific MDMA formulation (not the MDMA you get from your guy!) out of Schedule I to either Schedule II, III, or IV.
Only upon rescheduling can the commercial rollout proceed.
But as we’ll look at in the next section, efforts are in place to reschedule Psilocybin and MDMA before FDA approval through federal legislation.
The Breakthrough Therapies Act
From the press release from New Jersey Senator, Cory Booker’s office:
“Today, U.S. Senator Cory Booker (D-N.J.) and U.S. Senator Rand Paul (R-KY) introduced the Breakthrough Therapies Act, legislation that would enable the Drug Enforcement Agency (DEA) to make the findings necessary to transfer breakthrough therapies involving Schedule I substances such as MDMA and psilocybin from Schedule I to Schedule II, which could help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs. Additionally, the bill would remove burdensome federal regulations that impede research and development of drugs that may be inappropriately listed in Schedule I despite their potential to save many lives.”
The bill’s architect, like the previously introduced Right to Try Clarification Act, is the non-profit policy and advocacy group Reason-for-Hope, which is working at the state and federal levels to craft policy for state and federally funded “Research-Based-Access” models (more on that here).
A key barrier to Research-Based-Access, or any research for that matter, is the schedule I status of psychedelics; you might say that it is the most critical constraint on advancing psychedelic research.
The current system is an expensive, slow, and bureaucratic slog that allows the DEA to titrate such research through its issuance of Schedule I licenses. It also prices out scientists without commercial or philanthropic support since federal research funding has been essentially absent to date.
Currently, the only way a substance is downgraded from Schedule I classification is through FDA approval for medical use—thus making what is fundamentally a scientific and public health question a matter of commercial appetite.
The Breakthrough Therapies Act (BTA) would lower the barrier to rescheduling by moving the goal line from FDA approval to Breakthrough Therapy Status—a designation awarded as early as Phase II and that has already been bestowed upon the three lead psychedelic FDA projects in MAPS, Compass Pathways, and Usona.
A reclassification from Schedule I to Schedule II for MDMA and Psilocybin would unlock perhaps the most impactful Research-Based-Access opportunity there is: Federally funded research within the Veterans Affairs.
This political wedge has been so effective for Reason for Hope and other groups engaging with policymakers.
It is a compelling and galvanizing narrative when framed as veterans being forced to break the law or leave the country to access treatment while dozens of others take their own lives daily, so much so that it fosters the rare instance of bipartisan agreement.
Executive Director of Reason for Hope, Brett Waters, tells me he thinks the bill can be part of a larger end-of-year bill and told me:
“Rescheduling MDMA and psilocybin from Schedule I to Schedule II - prior to FDA approval - reduces the regulatory barriers and costs of expanded access pilot programs and incentivizes more clinics to participate.
We hope that many lives will be saved by utilizing such pilot programs to begin a phased roll-out of MDMA- and psilocybin-assisted therapies for those who have exhausted available treatments (and would not qualify for clinical trials due to complex co-morbidities).”
Let’s hope it gets over the line.
Ground Hog Day for Spravato
It seems like only recently we covered the NHS’ decision NOT to cover Spravato for the treatment of depression.
That’s because it was just in June.
The U.K.’s National Healthcare System’s clinical decision-making body—the National Institute for Health and Care Excellence (NICE)—offers a reality check by again rejecting Spravato (esketamine) for use in the NHS.
The agency cites hefty costs and lackluster clinical evidence.
This is the fourth time NICE has officially rejected the use of Spravato in the NHS.
From the beginning, independent researchers voiced concerns about the data from clinical trials. For further reading on the safety and efficacy of Spravato, see the following:
Are we repeating mistakes of the past? A review of the evidence for
Esketamine for treatment-resistant depression: seven concerns about efficacy and FDA approval
Beckley PsyTech Announces Phase I completion
From the press release:
“Beckley Psytech... announced the successful completion of its Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), which is under development for Treatment Resistant Depression and Alcohol Use Disorder…
Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. BPL-003 demonstrated rapid onset of effect within minutes and a short duration of experience, with all consciousness-altering effects resolving within 90 minutes. With the robust data generated thus far from this Phase I study, Beckley Psytech is now preparing to initiate its MHRA-approved Phase IIa studies evaluating BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder in Q4 2022.”
As noted in the study registry at Clinicaltrials.gov, the primary outcome for the Phase I trial in healthy adults was Treatment-Emergent Adverse Events (TEAES).
When they become available, secondary outcomes will also be telling as they include peak plasma concentration and time to reach maximum concentration.
5-Meo-DMT is fabled for its short duration but intense consciousness-altering effects, leading to the increasingly widespread underground use because of the economies of scale.
Tactogen Launches Stakeholder Investment Round
Tactogen has launched an ambitious project using the crowdfunding platform WeFunder to enable non-accredited investors to invest in the company.
“We’re the first drug development company in this sector that we know of to open our doors to non-accredited investors (that means you!). We want to include the community early on to participate in the value creation process.
We aim to include all those who will be affected by the development of psychedelics and related medicines. We’d like therapists, healers, nurses, physicians, scholars, researchers, activists, students, and patients (whether current or future) to all feel welcome as shareholders and participants in Tactogen.”
The Tactogen team brought in non-profit pharma veteran Victoria Hale as the lead investor in the community stakeholder initiative.
The team held its first Town Hall event to share its vision.
As of this writing, the team has raised nearly $45,000 of the $50,000 goal, and full disclosure, as of ten minutes ago, I am now an investor in Tactogen PBC.
Notice of Information on NIMH’s Considerations for Research Involving Psychedelics and Related Compounds
Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus
The German Government is funding psilocybin research with a $2.6 M grant
BMI does not predict response to psilocybin
A new industry report from Jeffries titled: Capitalizing on Consciousness
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