In this edition of "Rising High," The Fly conducted an exclusive interview with Michael Mullette, chief operating officer of MAPS Public Benefit Corporation, a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies. Here are some highlights:
COO APPOINTMENT: MAPS PBC, which seeks to catalyze healing and well-being through psychedelic drug development, therapist training programs and sales of prescription psychedelics, appointed Michael Mullette as COO in March. Mullette, who has spent over 20 years in the pharmaceutical industry, most recently served as vice president and managing director of North America for Moderna (MRNA), where he oversaw commercialization of the company’s COVID-19 vaccine. “The aim of my role is to help as we shift from an organization that was focused on development of MDMA-assisted therapy to one focused on commercialization and licensure approval of that therapy,” he said. “Those skill sets are different and those experiences are different as we start to think about entering the marketplace. Hopefully we’re just a short time away from an actual launch.” Coming from Moderna, the COO said any company developing a pharmaceutical product for commercialization has a lot to consider. “There are rules and regulations by which we are allowed to engage with the medical community as well as the consumer community that we need to stand up and be ready for as an organization,” he said. “There are internal processes, systems and tools that we need to build to be able to support access for patients upon approval and these things take time.” Mullette said while the world of vaccines and MDMA-assisted therapy on paper seem quite different, the activities MAPS PBC will need to conduct as an organization are quite similar. ”We need to work with payors to support reimbursement, we need to work with healthcare providers to help ensure that accurate scientific data has been disseminated appropriately and then eventually post-launch, we need to communicate benefit and safety of product to the consumers in a way that can be trusted,” he said.
MENTAL HEALTH FOCUS: MAPS PBC was founded in 2014 by MAPS, a 501(c)(3) non-profit research and educational organization, and is the parent company of MAPS EU, established to organize and administer clinical trials of MDMA-assisted therapy for post-traumatic stress disorder in the United Kingdom and European Union. “Mental health is a focus of the world right now,” the COO said. “The pandemic and COVID-19 has probably heightened that sense of focus on mental health and well-being. But trauma, specifically PTSD, that has been something that patients have been struggling with for years.” He noted the industry has developed products to help with symptoms, including depression and anxiety, but has not discovered ways to solve the challenges that many people feel with PTSD. “That’s where MDMA-assisted therapy comes in,” Mullette said. “What’s important to understand about the prescription and therapy regimen that we’re developing is that it is just that: It is a drug in the MDMA and it is also a therapy to support patients who are processing their trauma .” MAPS PBC seeks to put patients first, he said, through accessible mental health treatments for those who are in need and a commitment to open-science principles. “What’s really important for our organization is to ensure quality therapy care as well as quality and safe delivery of the pharmaceutical product so that these two things together can have the most patient benefit,” the COO said.
MDMA-ASSISTED THERAPY: When asked about the organization’s current focus on MDMA-assisted therapy for PTSD, Mullette cited the importance of identifying a patient population that could benefit from pharmaceutical and/or therapeutic development. “I have to give the credit to our founder Rick Doblin, who years ago identified with the help of other people in the space that patients suffering from PTSD would likely benefit most from MDMA-assisted therapy,” he said. “We also have to understand where the unmet medical need is and the need really is in patients suffering from PTSD.” When asked about the potential benefits of the therapy for patients, the COO pointed to the fact that patients facing trauma typically have a very difficult time in revisiting that trauma. “Typical psychotherapy will focus on revisiting that trauma in a way that is as comfortable for the patient as possible, but in order to address trauma, it’s often helpful to be able to talk about it,” he said. “What MDMA does is helps to reduce the fear complex that people have when dealing with an associated trauma from their past.” Mullette said in clinical trials to date, the organization has seen that when patients are able to undergo MDMA-assisted therapy, they’re able to deal more actively with their trauma in a way that can be therapeutic for them. “In the past, perhaps those patients haven’t been able to process their trauma fully or have the time or capacity to talk about that, because they’ve been too afraid or uncomfortable to actually dive into some of those traumas,” he said. “By putting the therapy and pharmaceutical together we hope that will help reduce the fear within the patient and address the trauma.”
PHASE 3 TRIAL: In May of last year, MAPS announced the publication of results of its first Phase 3 clinical trial of MDMA-assisted therapy for PTSD in Nature Medicine. The study found among participants with severe, chronic PTSD who received MDMA-assisted therapy, 88% experienced a clinically-significant reduction in symptoms and 67% no longer qualified for a PTSD diagnosis. “It’s really exciting and one of the reasons I joined is certainly reading the clinical data and the publication,” the COO said. “It’s extremely important to understand that this is the first time in a Phase 3 clinical program that we’ve been able to demonstrate the results that we did, which was a statistically significant change in the MDMA-assisted therapy versus placebo.” Following the data, MAPS is working on a confirmatory second Phase 3 program, he said. “Once the second Phase 3 program is complete, we will continue to pursue our filing of our new drug application with the FDA and work with them toward approval,” Mullette said.
MDMA SYNTHESIS: In April, MAPS and MAPS PBC announced the development of the first validated commercial synthetic process for producing multi-kilogram batches of MDMA under current Good Manufacturing Practices. ACS Omega, a journal of the American Chemical Society, recently published “Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA”, a paper describing the fully validated cGMP synthesis of up to 5 kg of MDMA in a four-step process beginning with a non-controlled starting material. When asked about the organization placing the process in the public domain, Mullette said it is key to MAPS PBC’s mission to be open and transparent about all its activities in pharmaceutical-assisted therapy development. “It’s just part of our practices to let the world know what we’re working on,” he said. “We have millions of people around the world who are really interested in our challenges and our successes and for us, our transparency is key.” When discussing the significance of the multi-kilogram synthesis, the COO said it’s important for MAPS to demonstrate that it has good control over the manufacturing processes for the MDMA the organization is producing. “It’s really important to understand that when people in the public think about something like MDMA, they might be thinking of something that is more of a recreational product,” he said. “Often times that is not MDMA actually in it’s pure controlled form. What we want to continue to do is to build confidence in our industry and our practices to show that we do things effectively and up to standard. We hope that leads to increased patient excitement about the type of work that we’re doing.”
SCHEDULE 1 DRUG: The Drug Enforcement Administration currently places MDMA in Schedule I of the Controlled Substances Act, meaning the drug currently has no accepted medical use. “If a drug is approved by the FDA, you would imagine that a rescheduling or a scheduling would occur,” the COO said. “Upon FDA approval, you would obviously have proven that there is a medical use, so we would expect that occur.” He added he does not expect the process to be simple and believes it would require a lot of work with regulators to do appropriately. “In terms of public confidence, I think it’s fair to say that the general public’s views on the use of psychedelics was significantly impacted by the scheduling of MDMA and other products over the last 20 years,” Mullette said. “Certainly I think our industry has a great deal to do to build confidence across all of the potential benefits of this medicine-assisted therapy.” That’s why transparency and openness are key pillars in MAPS PBC’s mission, he said. “An open book policy is so important,” the COO said. “One of the best ways to build trust is to make sure that we’re very open about all our activities, our clinical programs, our safety profiles and our manufacturing processes so that people can feel more comfortable.”
CHALLENGES: When looking at the largest hurdles facing the psychedelics space, Mullette pointed to the emerging nature of the industry and MAPS role as a trailblazer. “It’s hasn't been done before,” he said. “We have not been able to approve through the FDA or any regulator the use of a psychedelic-assisted therapy and I think the first time is always the most difficult.” Over the next 18-24 months, the organization will really focus on doing a great job with its data, clinical trials and work with the FDA, to ensure the agency has whatever it needs to provide its support and licensure, the COO said. “Then we will eventually focus on patient adoption,” he said. “We think this is a tremendous benefit for people in our clinical programs and we hope to bring that to patients around the world.”
OPPORTUNITIES: As the psychedelic industry develops and matures, the COO said there will be different opportunities for drug development companies versus providers administering the pharmaceuticals. “If we’re talking about the latter, there is a tremendous amount of support that needs to be done within the healthcare landscape to support mental health,” he said. “For example, today it is very difficult for people to find therapists.” Mullette noted there are not enough therapists to support the needs of the population and access to therapists in different areas of country is not equal. “Making sure we have open and equal access to all populations is critical,” he said. “Providers can come into this space and help it, whether that be through physical locations of therapy centers, training of additional therapists or managing the logistics of reimbursement or appropriate pay for therapists. There is a tremendous amount of work that can be done.” For drug development companies, the COO said the opportunities lie in continuing to work with regulators to find the appropriate pathways to support safety in patients and clinical outcomes. “If we can do that, we can spur more innovation,” he said. “What we know about the pharmaceutical industry at large is that there needs to be trailblazers. At the PBC, we are out in front and we hope to bring MDMA-assisted therapy to the marketplace to help people who are suffering from PTSD. If we can do that,m that’s going to give a lot of confidence to the rest of the industry to pursue their goals.”
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