- Results from the placebo-controlled
investigator-initiated trial, conducted at the University Hospital
Basel (UHB), demonstrate the significant, long-lasting beneficial
effects of LSD and potential to safely mitigate symptoms of anxiety
and depression -
- Data further validates MindMed's therapeutic
approach and supports the clinical development of MM-120 for the
treatment of Generalized Anxiety Disorder -
- Data was featured in an oral presentation on
May 11, 2022 at 5:05am EDT / 10:05am
BST -
NEW
YORK, May 11, 2022 /CNW/ -- 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, today
announced that Prof. Matthias
Liechti and Dr. Friederike
Holze, MindMed collaborators at University Hospital Basel
(UHB), have released positive topline data from a Phase 2
placebo-controlled investigator-initiated clinical trial evaluating
LSD in the treatment of anxiety disorders. These findings were
presented in an oral presentation at London's PSYCH Symposium on May 11, 2022.
![Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed)) Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed))](https://mma.prnewswire.com/media/996320/Mindmed_Logo.jpg)
The topline data demonstrate the significant, rapid, durable,
and beneficial effects of LSD and potential to safely mitigate
symptoms of anxiety and depression. LSD (200 µg) treatment resulted
in significant and strong reductions of STAI-G scores 16 weeks
after treatment in the between-subjects analysis (least square mean
(± SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8
to -4.5, p=0.007). LSD was well-tolerated.
"We are encouraged by the positive data showing that LSD
produced rapid, strong and long-lasting reductions in anxiety and
depression symptoms up to 16 weeks post treatment compared with a
placebo," said Dr. Miri Halperin
Wernli, Executive President of MindMed. "These results
represent the highest quality research ever conducted with LSD in
anxiety disorders and provide contemporary confirmation of the
preliminary findings of the anxiolytic and antidepressant effects
of LSD in over 500 patients to date."
Dr. Halperin Wernli continued,
"The statistically significant, strong and long-lasting reductions
in STAI-G scores, combined with similarly rapid and sustained
responses in all secondary endpoint measurements, are extremely
encouraging. These results further support MindMed's clinical
development strategy. We look forward to using these findings to
advance our MM-120 program for the treatment of Generalized Anxiety
Disorder."
Prof. Matthias Liechti,
co-primary investigator of the trial, commented, "While
psychedelics including LSD have shown beneficial effects on
reducing anxiety, there has still been a need for a deeper
understanding of the mechanisms and the long-lasting effects by
which psychedelics exert their therapeutic effects. Thus, we
designed a robust, randomized, placebo-controlled clinical trial
with a long follow-up period to extend the promising findings of
previously conducted smaller, open-label trials. We are extremely
encouraged by the results presented today, demonstrating the
long-lasting and strong reduction in patients suffering from
anxiety. We look forward to reporting additional analyses and
further investigating the therapeutic potential of LSD for patients
suffering from anxiety disorders."
Details on the data presentations:
The presentation, titled "LSD as a Treatment for Anxiety
Disorders: New Evidence of Efficacy," was delivered by Dr.
Friederike Holze and Prof. Dr.
Matthias Liechti, co-primary
investigators of the trial and MindMed collaborators at University
Hospital Basel (UHB).
Key data and conclusions from the topline efficacy analysis
featured in the PSYCH Symposium presentation include:
- Primary Endpoint: LSD treatment resulted in significant and
strong reductions of STAI-G scores 16 weeks after treatment in the
between-subjects analysis (least square mean (± SE) change from
baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5,
p=0.007).
- A clinical response (reduction in STAI-G scores ≥30%) was
observed in 65% (13/20) patients in the LSD arm and in 9% (2/22)
patients in the placebo arm (p=0.003).
- Effects were maximal 2 weeks after the second LSD session and
sustained up to 16 weeks.
- All secondary endpoint measurements, including the HAM-D-21,
BDI, and SCL-90-R, showed similarly rapid and sustained responses
consistent with a lasting treatment effect on anxiety, depression,
and general psychiatric symptomatology.
- Acute positive effects or mystical experiences significantly
correlated with long-term therapeutic outcomes.
- LSD was well-tolerated: only one SAE was considered related to
treatment and consisted of acute transient anxiety and delusions
during an LSD session. There were no recorded instances of
treatment-emergent suicidal ideation with intent, suicidal behavior
or intentional self-injury.
About the Phase 2 Investigator-Initiated Clinical
Trial
The investigator-initiated, two-center, clinical trial
was a double-blind, placebo-controlled, Phase 2 trial that
investigated the safety and efficacy of LSD for the treatment of
anxiety disorders. The trial enrolled 46 patients either suffering
from anxiety symptoms in life-threatening illnesses or with an
anxiety disorder without severe somatic illness. Patients were
randomly assigned to two sessions with either oral LSD (200 µg) or
placebo administration over a trial duration of 52 weeks per
patient. The primary efficacy endpoint was reduction in anxiety
symptoms 16 weeks after the last LSD or placebo administration. The
primary outcome measure was the State Trait Anxiety Inventory
(STAI) global score, which is used to assess the severity of
anxiety symptoms. Secondary outcome measures included improvements
in Hamilton Depression Scale (HAM-D), Beck Depression Index (BDI),
and several other major psychiatric symptoms
(Symptom-Check-List-90-R) scores. For additional information on
this trial see clinicaltrials.gov [NCT03153579].
MindMed supports the UHB Liechti Lab in conducting
investigator-initiated trials for LSD 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 products to treat brain
health disorders, with a particular focus on psychiatry, addiction,
pain and neurology. 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 drug candidates, with and without acute
perceptual effects, targeting the serotonin, dopamine and
acetylcholine systems.
MindMed trades on the NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the
symbol MMED.
Forward-Looking Statements
Certain statements in this
news release related to the Company constitute "forward-looking
information" within the meaning of applicable securities laws and
are prospective in nature. Forward-looking information is not based
on historical facts, but rather on current expectations and
projections about future events and are therefore subject to risks
and uncertainties which could cause actual results to differ
materially from the future results expressed or implied by the
forward-looking statements. There are numerous risks and
uncertainties that could cause actual results and the Company's
plans and objectives to differ materially from those expressed in
the forward-looking information, including history of negative cash
flows; limited operating history; incurrence of future losses;
availability of additional capital; lack of product revenue;
compliance with laws and regulations; difficulty associated with
research and development; risks associated with clinical trials or
studies; heightened regulatory scrutiny; early stage product
development; clinical trial risks; regulatory approval processes;
novelty of the psychedelic inspired medicines industry; as well as
those risk factors discussed or referred to herein and the risks
described under the headings "Risk Factors" in the Company's
filings with the securities regulatory authorities in all provinces
and territories of Canada which
are available under the Company's profile on SEDAR at www.sedar.com
and with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
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