As it inches closer to FDA submissions for its psychedelic drug candidate, Definium Therapeutics is laying the groundwork for a future launch with an educational push about the pharmaceutical potential of lysergide (LSD).
Definium—known until only recently as MindMed—on Tuesday unveiled an initiative aimed at familiarizing the public with LSD as a potential treatment for various psychiatric and neurological conditions.
The “Rerouting Minds” webpage comprises information about LSD’s clinical history dating back to the 1930s, about how psychedelics may enhance neuroplasticity to treat conditions originating in the brain and about Definium’s own approach to developing pharmaceutical LSD.
According to the campaign, the drug has the potential to narrow what the company termed the “mental health treatment gap,” in which current treatments for conditions like depression and anxiety are ineffective for many of the millions of U.S. patients who need them.
The page also includes several links to learn more about and sign up for clinical trials of Definium’s LSD formulation for anxiety, as well as to external sources offering more information on the therapeutic potential of psychedelics.
“Our scientifically rigorous efforts within the psychedelic renaissance are reshaping how we understand LSD’s role in mental health care and as a potential next step in the treatment journey,” Dan Karlin, M.D., Definium’s chief medical officer, said in this week’s announcement. “The ‘Rerouting Minds’ campaign highlights the science for clinicians and decision-makers, helping build awareness of the transformative potential of pharmaceutical LSD and what it can offer patients who are struggling in today’s mental health crisis.”
The campaign arrives amid the ramp-up of Definium’s commercial preparations, as the company is expecting to deliver three phase 3 readouts throughout the coming year.
Its lead candidate, DT120 ODT, is currently being tested in generalized anxiety disorder and major depressive disorder. Results from two anxiety trials are expected in the second quarter and second half of this year, respectively, while data from another trial in depression will arrive around the middle of the year, which is also when a second phase 3 trial in the indication will kick off, according to a timeline Definium laid out while announcing its name change early last week.
Elsewhere, the company has also begun a phase 2a study of DT402, a formulation of MDMA, in adults with autism spectrum disorder.