ATAI adds MDMA biotech to growing list of psychedelic makers; Acadia adds $52.5M upfront pain buyout
For years, the biggest push in psychedelic drug development has been around MDMA, a party drug long thought to have potential benefits for patients with PTSD. Rick Doblin, for years psychedelic therapy’s most prominent advocate and fundraiser, and his non-profit, MAPS, have raised millions to advance clinical trials, most recently raising $30 million to complete a Phase III study in veterans.
But ATAI, the German-born biotech that has quickly become the most prominent private promoter and driver of psychedelic therapy, still thinks they have something to offer. Yesterday, the portfolio announced their latest subsidiary: EmpathBio.
The idea behind EmpathBio is that Doblin’s approach, while promising, will only represent MDMA 1.0. In a 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. The problem, said ATAI CSO Srinivas Rao, is that the drug has to be administered over multiple days in facilities where patients are supervised by trained professionals for hours.
“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.”
The company remains far from the clinic, but they will work on MDMA-like compounds that they say have a better profile. With at least one other company, notably Kures, ATAI and its subsidiaries have tweaked generic, plant or other non-patentable molecules in large part to make them patentable, ensuring there’s a viable commercial pathway.
But EmpathBio CEO Glenn Short pointed to the potential for some of these tweaks to reduce hypertension of MDMA, allowing it to be given patients with co-morbidities, as well as allowing it to be given over shorter periods of time and in less controlled settings, allowing patients to receive the drug in rural and other areas.
Acadia adds to pain pipeline
Acadia has been adding to its pipeline of late, most recently picking up new Alzheimer’s and dementia candidates in a milestone-heavy deal with Vanderbilt University. Now, in a larger deal, they’ve added a new preclinical and early-stage clinical pipeline of pain drugs, buying out CerSci Therapeutics for $52.5 million upfront and $887 million in milestones.
The company had been developing for multiple neurological indications but had been focused on non-opioid painkillers for acute and chronic pain. A lead compound, ACP-044, was shown tolerable in Phase I studies. Acadia said a Phase II study is planned for next year.