PRESS RELEASE: MAPS Completes $4 Million Matching Grant from Pineapple Fund
• Cryptocurrency philanthropist inspires $4 million in donations from over 550 individuals and foundations in less than eight weeks
• MAPS has now raised all but $500,000 of the $26.7 million needed to complete FDA Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD
Brad Burge, Director of Strategic Communications, MAPS
Santa Cruz, Calif.—Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the successful completion of the $4 million matching grant from the Pineapple Fund for U.S. Food and Drug Administration (FDA) Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).
On January 10, 2018, the Pineapple Fund, created by an anonymous cryptocurrency philanthropist known only as “Pine,” announced that they would match the next $4 million in donations to support MAPS’ upcoming Phase 3 trials, with a deadline of March 10. The announcement inspired $4 million in new gifts from over 550 individuals, which the Pineapple Fund has matched in Bitcoin, for a total of $8 million. 149 of these new gifts, totaling $1,093,330, were received in cryptocurrency.
With these gifts, MAPS has now raised $26.2 million of the $26.7 million needed for its upcoming FDA Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. MAPS now needs only an additional $500,000 to complete funding for the final stage of research needed to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD in the U.S. MAPS is currently seeking an additional $5 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA.
“Pine’s extraordinary generosity has inspired many others to rise to the challenge of his $4 million matching grant,” said Rick Doblin, Ph.D., MAPS’ founder and executive director. “We can now truly say that MDMA-assisted psychotherapy will be a gift to the world from the psychedelic and cryptocurrency communities, with MAPS having been unable to obtain any government funding for our research. “
On behalf of the millions of people and families who will benefit from legal MDMA-assisted psychotherapy for PTSD when it’s approved, MAPS expresses its sincere gratitude to all of the individuals and foundations who contributed to the Pineapple Fund matching grant. Leading contributors to the match included George Sarlo ($1,000,001), James Evans ($1,000,000), Libra Foundation ($600,000), anonymous ($400,000), William H Donner Foundation ($250,000), Jason Dorsett ($200,000), Christian Halper ($200,000), Bo Shao and Oleg Gorelik ($148,235), Cyan Bannister ($50,000), George Goldsmith and Katya Malievskaia ($25,000), James Bailey and Devon Aoki ($10,000), Robert Bienstock ($10,000), and Fred and Katie Weber ($10,000).
[EDIT: Although the original version of the release did not include this list, MAPS also thanks Paul and Kristina Eklund ($7,000), Robert Barnhart ($5,000), Ginger and Brad Coy ($5,000), Dale Okuno ($5,000), Joe Polish ($5,000), Jamie and Julie Wheel ($5,000), and Jeffrey Zucker ($5000) for their generous contributions to the match.]
On July 28, 2017, MAPS obtained an Agreement Letter from the FDA regarding our Phase 3 protocol design, successfully concluding FDA’s Special Protocol Assessment (SPA) process. On August 15, 2017, based on the results of MAPS’ Phase 2 trials, the FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review.
On March 1, 2018, MAPS had its first meeting with the European Medicines Agency (EMA) to plan the Phase 3 research that will be required to obtain approval for MDMA-assisted psychotherapy for PTSD in Europe.
Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD will begin in the summer of 2018, and will enroll 200-300 participants across 16 sites in the U.S., Canada, and Israel. Provided the Phase 3 trials demonstrate statistically significant efficacy and an acceptable safety profile, FDA approval is expected by 2021.
In MAPS’ completed Phase 2 trials with 107 participants, 68% no longer qualified for a diagnosis of PTSD twelve months following treatment. These participants all had chronic, treatment-resistant PTSD, and only required three sessions of MDMA-assisted psychotherapy, along with twelve 90-minute psychotherapy sessions for preparation and integration.***
Every year in the U.S., 8 million people are suffering from PTSD, with an estimated 300 million PTSD sufferers worldwide. With approximately 27% of suicides in the U.S. associated with PTSD, and an average of 20 veterans committing suicide every day, there is an urgent need for more effective treatments for PTSD.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $47 million for psychedelic therapy and medical marijuana research and education. As a non-profit with no government funding for psychedelic research, MAPS relies on contributions from individuals, businesses, and foundations. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2015 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapsbcorp.com.
***NOTE: This paragraph has been updated from the original version, which reported that 61% of participants no longer qualified for PTSD after 2 or 3 sessions. This percentage incorrectly included participants whose data was not included in the final report due to study drop-outs and other reasons. The correct number, 56%, is reported above. There is no change to the long-term (12-month) follow-up data.