Mind Medicine has presented positive topline data in Basel, Switzerland in April from a double-blind, investigator-initiated trial evaluating lysergide (LSD) in the treatment of Major Depressive Disorder (MDD).
Professor Matthias Liechti and Dr Felix Mueller, MindMed collaborators at University Hospital Basel (UHB) and the University Hospital of Psychiatry, released the data, which demonstrated significant, rapid, durable and beneficial effects of LSD and its potential to mitigate symptoms of MDD.
The high dose LSD regimen saw patients receive 100 µg at their first dosing day and 200 µg at their second dosing day (separated by four weeks).
Mind Med has stated that the results saw statistically and clinically significant improvements on the primary endpoint, which was the change in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores six weeks after the first administration as compared to control (whether or not the patient received a second administration).
The control group in this study received a lower dose regimen of 25 µg on both treatment days.
According to the company, the patients in the high dose arm demonstrated a least-square mean change from baseline in IDS-C scores of -12.9 points compared to -3.6 points in the lower dose arm. The statistically significant benefit as measured by IDS-C was maintained up to 16 weeks after the first administration compared to placebo.
Data from the secondary endpoints were also encouraging. The investigational drug was generally well-tolerated, as indicated by reported adverse events, changes in vital signs and laboratory values.
CEO and Director of MindMed, Robert Barrow, stated: “We continue to be encouraged by the positive results being generated on the clinical activity of lysergide by our collaborators at UHB.
“The statistically and clinically significant improvements observed in this study reinforce preliminary findings that have shown the clinical potential of lysergide in anxiety, depression and other brain health disorders. These positive findings are particularly relevant to our MM-120 program in generalised anxiety disorder [GAD], given the high degree of comorbidity of GAD and MDD.
“I would like to congratulate and thank our collaborators at UHB for once again generating high quality clinical data that continue to support the progression of our pipeline.”
Professor Liechti, co-primary investigator of the trial, commented: “Historical studies of lysergide in MDD demonstrated rapid, robust and sustained improvement in depressive symptoms.
“We also observed improvement in depressive symptoms in patients with anxiety disorders in another of our recently published trials. We believed it was necessary to confirm the historical studies with ones using modern methods.
“Hence, we designed this randomised-controlled trial to assess the benefits of lysergide treatment in MDD. Importantly, an active small dose of lysergide was used as the control.
“We are extremely encouraged by the results we presented today, which demonstrate the strong, rapid and enduring improvements of this compound in patients suffering from MDD. We look forward to publishing the completed results in a peer-reviewed journal along with additional analyses. Our lab will continue investigating the therapeutic potential of lysergide and other psychedelics.”
