A biopharmaceutical company dedicated to psychedelic treatment announced last week that its clinical trial on MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”) produced encouraging results.
The company, MAPS Public Benefit Corporation, said that it had completed “confirmatory phase three” of the multi-site study, which “met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (‘CAPS-5’) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (‘SDS’).”
“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation.
Last week’s announcement comes after the company said in November that it had completed “the second of two Phase 3 pivotal trials.”
“Now with two positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year,” Emerson said last week.
The study, known as “MAPP2,” was “a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD,” the company said last week.
“The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more than half of those enrolled in the study,” the company said in a press release.
Founded in 2014, MAPS Public Benefit Corporation says that its vision is to create a “world where all people have opportunities to heal and grow through psychedelic medicines and therapies.”
The company’s mission statement reads: “Lead the research, development, and integration of psychedelic medicines and therapies into the healthcare system, prioritizing purpose over profits.”
That mission has been buttressed by the the U.S. Food and Drug Administration, which in 2017 “granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies,” the company said in last week’s press release.
“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Emerson said in 2017. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”
The company said last week that it “expects to submit the new drug application to the FDA in the third quarter of 2023.”
“MAPS PBC plans to submit the full data set for publication in a peer-reviewed journal,” the press release said. “MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.”