MAPS PBC Announces Positive Topline Results from Long-Term Observational Follow-Up Study on MDMA-Assisted Therapy for Treatment of PTSD

• Interim results show improvements in PTSD symptom severity lasted at least six months after the last treatment session 
• Findings are consistent with previously published Phase 2 data¹ on the sustained effect of MDMA-assisted therapy for the treatment of PTSD

SAN JOSE, Calif., April 5, 2023 /PRNewswire/ -- MAPS Public Benefit Corporation ("MAPS PBC"), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced positive topline results from an observational follow-up study evaluating the long-term safety and efficacy of MDMA-assisted therapy for post–traumatic stress disorder ("PTSD"). Preliminary findings show that participants in this study demonstrated a durable response at least six months, and in some cases a year or more, after their final MDMA-assisted therapy session during the Phase 3 study.

"PTSD is a chronic condition when insufficiently treated and has historically been addressed through long-term maintenance treatment, which is why it's important to evaluate whether an acute treatment like MDMA-assisted therapy has an enduring response when used to treat PTSD," said Amy Emerson, chief executive officer, MAPS PBC. "These results are consistent with previously published Phase 2 data demonstrating the sustained effect of MDMA-assisted therapy at least 12 months following treatment and suggest the acute treatment effect could last even longer."

In the two Phase 3 studies, participants who received therapy with MDMA showed significant improvement over therapy with placebo when measured at two months after the last experimental session, meeting the primary and secondary endpoints. Following the final treatment session, participants went back to their daily lives and then were able to participate in this long-term follow-up study by agreeing to complete an assessment at least six months after their last therapy session with MDMA or placebo. The primary objective of this study was to evaluate the long-term effectiveness of MDMA-assisted therapy for the treatment of PTSD as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score.

Preliminary interim findings show that participants in this study demonstrated durable improvements in PTSD via CAPS-5 Total Severity scores at least six months after the last dosing session. Follow-up data continues to be collected from participants. Results also showed the effects of treatment were maintained in participants who were followed up within a year as well as those who were followed more than a year later. There was also a low incidence of relapse following treatment response or loss of PTSD diagnosis, and an even lower incidence of relapse following remission. These results were consistent with previously published Phase 2 data suggesting sustained effectiveness of MDMA-AT for the treatment of PTSD.

About MDMA
MDMA (3,4-Methylenedioxymethamphetamine) is an entactogen - a class of psychoactive drugs that produce experiences of emotional communion, oneness, relatedness, emotional openness and are thought to have use for various medical conditions.² In the 1960's and 1970's MDMA was used in conjunction with psychological therapy by mental health providers to enhance patients' access, processing, and communication of difficult emotions and experiences.³ In 1985, the U.S. Drug Enforcement Agency ("DEA") made MDMA a Schedule I drug under the Controlled Substances Act preventing it from being used for recreational or medical use.⁴ Since then, research has shown the unique properties of MDMA allow it to act as a powerful catalyst to support psychotherapy by helping attenuate the brain's fear response allowing patients to access and process painful memories without being overwhelmed.⁵ With a growing body of evidence supporting the potential medical use of MDMA, in 2017 the U.S. Food and Drug Administration ("FDA") granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite the development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies. MAPS PBC expects to submit a new drug application including data from two Phase 3 studies that showed clinically significant improvements in PTSD symptoms following acute treatment with MDMA-assisted therapy to the FDA in the third quarter of 2023. If approved by the FDA, the DEA would reschedule MDMA making it available for prescription medical use. MDMA-assisted therapy is also being studied in other indications.

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.

ABOUT PTSD
PTSD is a serious public health issue affecting approximately 13 million Americans each year⁶, yet currently available treatments only provide modest efficacy.⁷ People with PTSD can experience debilitating symptoms that impact nearly all areas of a person's life.⁸ They also frequently suffer from serious comorbidities including anxiety, depression, and substance use disorder.⁹ PTSD has an enormous economic impact resulting in an annual burden of over $200 billion.¹⁰ Currently available treatments for PTSD are inadequate to address the full spectrum of patients who need treatment and do not provide adequate relief from debilitating symptoms.⁶ These limitations combined with high treatment discontinuation rates¹¹ underscore the urgent need for novel and effective therapies.

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC) 

MAPS Public Benefit Corporation (MAPS PBC) is focused on developing and commercializing prescription psychedelics to bring better treatments to those living with mental health conditions. Founded in 2014, MAPS PBC is a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization. For more information, please visit www.mapsbcorp.com.

MEDIA CONTACT
Blair Clark-Schoeb
Chief Communications Officer
[email protected] 

¹ Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4. PMID: 32500209; PMCID: PMC7351848.
² O'Neil, M.J., The Merck Index: An Encyclopedia of chemicals, drugs and biologicals. Merck Research Laboratories, Merck and Co. Inc, Whitehouse station, New Jersey, 2006. 319
³ Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. J Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712. Epub 2017 Jun 21. PMID: 28635375; PMCID: PMC5544120.
⁴ National Institute on Drug Abuse What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (nih.gov)
⁵ Yazar-Klosinski B, Mithoefer MC. Potential Psychiatric Uses for MDMA. Clinical Pharmacology & Therapeutics, 2016 Nov 9. https://doi.org/10.1002/cpt.565
⁶ VA National Center for PTSD. US Department of Veterans Affairs. Accessed February 14, 2023. https://www.ptsd.va.gov/understand/common/common_adults.asp
⁷ Morina N. Remission from post-traumatic stress disorder in adults: a systematic review and meta-analysis of long term outcome studies. Clin Psychol Rev. (2014) Apr;34(3):249-55. doi: 10.1016/j.cpr.2014.03.002.
⁸ The Mayo Clinic, PTSD, Symptoms and Causes www.mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-20355967c
⁹ Grinage B.D. Diagnosis and Management of Post-traumatic Stress Disorder. Am Fam Physician. (2003);68(12):2401-2409.
¹⁰ Davis LL. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. J Clin Psychiatry. (2022) Apr 25;83(3):21m14116. doi: 10.4088/JCP.21m14116.
¹¹ Varker T. Dropout from guideline-recommended psychological treatments for posttraumatic stress disorder: A systematic review and meta-analysis. Journal of Affective Disorders Reports (2021) Apr 2021, 100093. doi: 10.1016/j.jadr.2021.100093

SOURCE MAPS PBC