EXCLUSIVE: MDMA Therapy Experts Debate Upcoming Approval And Psychedelic Market Opps

In the current psychedelics landscape, one of the most important topics is compound legality. 

While it's possible that MDMA-assisted therapy will eventually be federally approved in the U.S., what should investors consider when looking at a prospective business?

The 2023 edition of Benzinga’s PCC invited Clerkenwell Health CCO George McBride, MAPS PBC COO Michael Mullette, Iter Investments co-founder Robert Velarde and PharmAla Biotech CEO Nick Kadysh, along with attorney Courtney Barnes as moderator, to further elaborate on the topic.

The Complexities Of Psychedelics Clinical Trial Regulations

McBride acknowledged how difficult it is to conduct psychedelics research. Clerkenwell spent an extra £1 million on security along with bias, blinding, and other factors that traditional research organizations do not face when running trials.

The CRO’s aim is to optimize psychedelics treatment synergistically with talking therapies in a cost effective, scalable way that regulators can understand and engage with.

Following Brexit, U.K. regulator MHRA has undergone its own significant changes, including losing much of its funding, changing in shape and size, and now trying to pursue a new agenda with a new scheme to eventually authorize FDA-approved drugs, McBride explained. This means changes in commercialization strategies, specifically for upcoming MDMA.

“So there's an interesting new dynamic in the U.K.,” McBride added.

Breakthrough Therapy Designation, Quality And Patient Safety

MAPS’ long-standing study of MDMA for PTSD treatment is founded on the belief that the substance helps patients talk more openly about their traumas, Mullette says. 

With the given Breakthrough Therapy designation, MAPS is able to engage with the FDA much more proactively, in “a two-way dialogue” facing instances like the clinical program’s design, in which the agency tries to work supportively with the available data at a “reasonable” timeframe.

Positive data from the latest Phase 3 study will be published this spring/summer, following which MAPS would file with the FDA and after that, Mullette says, it’s really up to the agency to review the drug application.

The core principles traversing everything within the industry are quality and patient safety. “That will just spur confidence, and that confidence will spur investment for other ideas, creativity expansion, but we have to start with that in mind first,” Mullette said.

Verticals Specificities And Execution As Fundamentals

Velarde, an experienced investor and venture capitalist focused on psychedelic therapies for mental health, remains “very encouraged” despite industry challenges.

“There is commercial opportunity” in today’s scenario, he says.

Iter is directly involved in MDMA’s federal pending approval that would constitute a major milestone for the industry as investors in MAPS PBC. 

The fund is also investing in companies working with MDMA and delivery technologies, such as Awakn AWKNF, and others developing New Chemical Entities (NCEs.) All of which, Velarde explained, have different development timeframes.

Primary investor concerns are around capital but also safety. Iter invests across different verticals, each requiring an individual analysis but always keeping in mind market opportunity and company resources.

“Specifically, the management team, IP, the business model and scalability.” Bringing in the right people to the space is as important as crowding financial capital, because “at the end of the day, it's about execution.”

MDMA As Pro-Social, Canadian Regs, And Global Market

Kadysh leads an “MDXX-class molecules” company. That means PharmAla works both as an MDMA provider and also develops novel analogs for specific populations of concern.

MDMA provides a pro-social experience — making socialization more fluid. This is partly the reason why MAPS has had success developing it as a PTSD treatment.

Canada’s new SAP rules allows use of psilocybin and MDMA, but the issue is the approval process is still “very, very burdensome," Kadysh explained.

The program was not designed for psychedelic molecules but rather orphan drugs for rare diseases and that situation has in fact propelled an important lawsuit against the federal government for patient access.

Australia, an OECD country, has legal MDMA therapy available for certain patients and which would work as a “very interesting case study” for future treatment rollout in other places, Kadysh says.

Photo: Benzinga edit with photo by curiosity and Andrei Verner on Shutterstock.