Mind Medicine (MindMed) has reported positive topline data from a Phase ll trial of lysergide to treat major depressive disorder (MDD).

The results were released by MindMed collaborators at University Hospital Basel (UHB) and the University Hospital of Psychiatry professor Matthias Liechti and Dr Felix Mueller.

Liechti is the co-primary investigator of the double-blind, active-controlled trial that enrolled 61 patients to assess the safety and efficacy of lysergide.

The high dose lysergide regimen, where patients were treated with 100µg at their first dosing day and 200µg at their second dosing day in a gap of four weeks, demonstrated statistically and clinically significant improvements on the primary endpoint of the trial.

The primary endpoint was the change in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores six weeks after the first dose versus the control group, irrespective of the patients receiving a second dose.

In the control group, patients were administered with a reduced dose regimen of 25µg on both treatment days.

Patients in the high dose arm showed a least square mean change from baseline in IDS-C scores of -12.9 points against -3.6 points in the lower dose arm.

Findings from the secondary endpoints were found to be significant. 

Lysergide, the investigational drug, was generally well-tolerated, as highlighted by reported adverse events as well as changes in vital signs and laboratory values.

Liechti said: “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.”