Researchers have released positive topline data from a trial evaluating microdoses of lysergide, commonly known as LSD, in the treatment of major depressive disorder (MDD). The investigator-initiated Phase 2 trial was led by Prof Matthias Liechti and Dr Felix Mueller at University Hospital Basel (UHB) and the University Hospital of Psychiatry, and supported by Mindmed.
Lysergide is a potent semi-synthetic hallucinogen that has gained some notoriety as an illicit drug but in recent years has been investigated as a treatment for MDD, alongside other psychedelic drugs. The new trial compared lower and higher doses of lysergide, though at still small doses. Previous research also showed benefits in treating anxiety.
The topline data demonstrated significant, rapid, durable and beneficial effects of lysergide and its potential to mitigate symptoms of MDD. The high dose lysergide regimen in which 28 patients received 100µg at their first dosing day and 200µg at their second dosing day (separated by four weeks) resulted in statistically and clinically significant improvements on the primary endpoint, which was the change in clinician-rated depressive scores 6 weeks after the first administration as compared to control (whether or not the patient received a second administration). The 27 members of the control group received a lower dose regimen of 25µg on both treatment days. Both groups had improvements compared to the placebo group. Data from the secondary endpoints were also encouraging, and the investigational drug was generally well-tolerated, as indicated by reported adverse events, changes in vital signs and laboratory values.
“We continue to be encouraged by the positive results being generated on the clinical activity of lysergide by our collaborators at UHB,” said Robert Barrow, Chief Executive Officer and Director of MindMed, the company behind the trial. “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 generalized anxiety disorder, 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.”
Prof. Matthias 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.”
MindMed supports the UHB Liechti Lab in conducting investigator-initiated trials for lysergide and other novel therapies and has exclusive access and rights to the data generated by these studies.
Source: MindMed
