Earlier this year, Psymposia published a story titled, Christian Angermayer’s ATAI Life Sciences is positioned to take the psychedelic throne from MAPS. In this article, we detailed how executives from for-profit companies are quick to point to the advances in psychedelic science made by nonprofits, allowing their venture-backed companies to speculate on the so-called “psychedelic renaissance.” A recent announcement from ATAI Life Sciences indicates that the company is moving closer to MAPS’ hallowed ground of MDMA research.

ATAI has added EmpathBio to their portfolio of psychedelic drug companies. Piggybacking on MAPS’ research from the last three decades, EmpathBio plans to develop MDMA derivatives to treat patients with PTSD.

An Endpoints News article highlighting an interview with ATAI’s Chief Scientific Officer, Srinivas Rao, characterized MAPS’ approach to treatment with MDMA as “MDMA 1.0.” The author of the article, Jason Mast, told Psymposia that this characterization came “from the ATAI folks.” Rao explained that ATAI sees a problem in the fact that, under MAPS’ model, MDMA must be administered over multiple days, with patients being supervised for hours by trained professionals. 

“The challenge with MDMA as it’s envisioned by MAPS is that it’s difficult to deploy and to scale up,” Rao told Endpoints News. “What we want to do is transition this more to an outpatient, or day-therapy type of approach, so we’re looking at compounds that are potentially safer.”

Rick Doblin, MAPS’ Executive Director, said that ATAI approached him before making this move into MDMA derivatives and he gave the company his “blessing” (noting, “Of course, they’d have done it anyway”). But, he said that his advice to ATAI was to pursue MDMA derivatives more suited for a recreational market, focusing on decreasing the “loss of magic” effect that many MDMA users experience over time, in which the effect of the drug—even at higher doses—is no longer as noticeable or effective. Doblin sees the loss of magic effect in an MDMA therapy setting as a potential, unintended boon for clinical use, as it decreases the likelihood of addictive behavior. 

While Doblin did give ATAI his “blessing” to move forward with EmpathBio, he takes issue with the framing of MAPS’ research in Rao’s correspondence with Endpoints News. The article notes that, “In a recent MAPS analysis of pooled Phase II studies – not a perfectly sound measure but good enough to support more studies – about half of the 100 patients who received the drug didn’t have the diagnostic symptoms for PTSD two months after their last dosing.” Doblin said that while these reported results are accurate, after a 12-month follow-up, closer to 67 percent of participants in MDMA therapy no longer showed symptoms of PTSD. 

The Endpoints News article continues, with EmpathBio CEO Glenn Short explaining that the hope for his company is to make a safer drug for clinical use that reduces hypertension caused by MDMA, and which can be given over shorter periods of time in less controlled settings. 

While MDMA can cause an increase in blood pressure, Doblin said that—as long as a patient with high blood pressure is controlled with medication—MDMA can generally be taken without any safety concerns. And, to the aforementioned points about scalability and required time from patients in MDMA therapy settings, Doblin noted that MAPS does prefer a two-therapist model to increase effectiveness and safety for patients. This may make MAPS’ protocol seem “less scalable,” Doblin said, but MAPS is planning to move to a model using one licensed therapist, and one student or intern. And, Doblin said that some of their trial locations are letting patients go home after therapy and forego overnight stays, decreasing the amount of time required of patients.

Referencing the characterization of MAPS’ approach in the EndPoints News article, Doblin said that, “If MAPS is ‘MDMA 1.0,’ I would say that what ATAI [and EmpathBio] is working on is ‘MDMA 0.5’”—referring to the fact that there is less available research on the drugs EmpathBio is developing, and that the company is seemingly developing less intensive therapy regimens for patients.