MindMed Collaborators Announce Positive Topline Data from Phase 2 Trial of Lysergide (LSD) in Major Depressive Disorder (MDD)
April 14 2023 - 7:00AM
Business Wire
– Primary endpoint achieved statistically
significant improvement in MDD symptoms –
– Confirmation of activity of lysergide in
brain health disorders with direct relevance to MindMed’s MM-120
program in Generalized Anxiety Disorder (GAD) –
– Data presented on April 14, 2023 in Basel,
Switzerland –
Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED),
(the “Company” or “MindMed”), a clinical stage biopharmaceutical
company developing novel products to treat brain health disorders,
announced today that Prof. Matthias Liechti and Dr. Felix Mueller,
MindMed collaborators at University Hospital Basel (UHB) and the
University Hospital of Psychiatry, have released positive topline
data from a double-blind, investigator-initiated trial evaluating
lysergide in the treatment of MDD. These findings were presented on
April 14, 2023 in Basel, Switzerland.
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 patients
received 100 µg at their first dosing day and 200 µg 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 Inventory
of Depressive Symptomatology (IDS-C) scores 6 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.
Patients in the high dose arm (n=28) 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 (n=27, p=0.02). The
statistically significant benefit as measured by IDS-C was
maintained up to 16 weeks after the first administration compared
to placebo (p=0.008). 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.
“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 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
randomized-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.”
About the Phase 2 Investigator-Initiated Clinical
Trial
The investigator-initiated clinical trial was a double-blind,
active-controlled, Phase 2 trial that investigated the safety and
efficacy of lysergide for treating 61 patients with MDD. Patients
allocated to the treatment intervention received 100 μg of
lysergide on the first dosing day and 200 μg on the second dosing
day, with dosing days separated by approximately 4 weeks. Patients
allocated to the active control intervention received 25 μg of
lysergide on the first dosing day and 25 μg of lysergide on the
second dosing day. The primary efficacy endpoint was improvement in
MDD symptoms six weeks after the first administration (2 weeks
after the second administration), as measured by the
clinician-rated Inventory of Depressive Symptomatology (IDS-C).
Secondary outcome measures included improvements in the self-rated
version of the Inventory of Depressive Symptomatology (IDS-SR),
Beck Depression Index (BDI), State-trait anxiety inventory
(STAI-G)) along with other psychiatric symptom assessments.
Patients were followed for up to 16 weeks following the first
dosing session. For additional information on this trial, see
clinicaltrials.gov [NCT03866252].
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.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel product candidates to treat brain health disorders. Our
mission is to be the global leader in the development and delivery
of treatments that unlock new opportunities to improve patient
outcomes. We are developing a pipeline of innovative product
candidates, with and without acute perceptual effects, targeting
neurotransmitter pathways that play key roles in brain health
disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the symbol MMED.
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