- MindMed,
a biotech company specializing in psychedelic-inspired medicines, has
revealed promising results from its MM-120 drug candidate in the treatment
of Generalized Anxiety Disorder (GAD).
- The
results from a recent clinical trial showed that the MM-120 — a
hallucinogen better known as LSD — could become a potential new treatment
for GAD, a condition that affects millions of people worldwide.
- The
trial highlight that the drug candidate, particularly at the 100 µg dose,
demonstrated effectiveness, significantly reducing anxiety symptoms.
Generalized
anxiety disorder (GAD) is characterized by persistent and
excessive worry or nervousness about everyday life, frequently causing
disruptions in daily tasks and personal connections.
Potential treatments
include psychotherapy, medication, and lifestyle adjustments.
GAD, categorized as an
anxiety disorder, is prevalent, affecting 3.1% of the United States population
in a given year, equivalent to 6.8 million adults. It is more frequently
diagnosed in women.
Coping with anxiety can
present difficulties, but like other anxiety disorders, GAD is eminently
manageable and responsive to treatment.
Mind Medicine
(MindMed) Inc., a clinical-stage biopharmaceutical company
specializing in innovative treatments for brain health conditions, has just
released promising findings from its Phase 2b clinical trial involving MM-120
(lysergide d-tartrate) for generalized anxiety disorder (GAD).
Dr. Daniel Karlin, chief medical officer
of MindMed, explained the key findings to Medical News Today:
“MindMed conducted this
study with participation from 198 patients, all of whom suffered with a primary
psychiatric diagnosis of generalized anxiety disorder (GAD), across 20 clinical
sites in the United States.”
“Participants were divided
into 5 study arms; each arm received a single dose of a lysergide-based drug
candidate, called MM-120 (lysergide d-tartrate), or a placebo,” Dr. Karlin continued.
“Among the four groups that
received a dose of MM-120, doses were 25, 50, 100, or 200 µg of MM-120.
Importantly, no form of additional therapy was given to any participant. The
study design evaluated the stand-alone effects of the drug candidate, MM-120,”
he further explained.
“The data available to us
at this time show that patients experienced meaningful and lasting symptom
reduction. Four weeks following a single dose of MM-120, 78% of participants
who received either a 100 or 200 µg dose measured as having a clinically significant
response to the drug. 50% of participants who received the 100 µg dose were
considered to be in clinical remission at Week 4, meaning that the patient no
longer suffered from clinically significant symptoms of GAD.”
— Dr. Daniel Karlin
The research results have
yet to be published in a peer-reviewed journal; however, the company plans to
submit the study for publication soon.
Do
psychedelics work for mental health?
Heather
Tarbet, Ph.D., vice president of research & development at Amani
Ag, told MNT that “this research presents several compelling
implications, especially in mitigating the challenges associated with
psychedelic therapy.”
“The study demonstrates the
tolerability of MM-120, which shortens psychedelic effects while preserving the
therapeutic benefits. This approach could alleviate safety and logistical
concerns, thereby making psychedelic therapies more accessible and widely
accepted among diverse patient groups.”— Dr. Heather Tarbet
Dr. Tarbet noted that “the
study’s insights could inspire progress in the broader field of psychedelic
research, potentially enhancing treatments for various complex mental health
conditions.”
“Moreover, by altering LSD
to lessen its intensity and duration, these treatments could gain broader
acceptance among patients, healthcare providers, and regulatory authorities,
paving the way for wider adoption in medical practice,” she said.
Early results
must be confirmed by real-world evidence
The preliminary
findings from early-phase studies should be corroborated and validated through
real-world evidence. This process ensures the reliability and applicability of
the trial results.
Dr. Walker Porterfield of Clarity
Hyperbarics urged caution about making definitive conclusions, telling MNT that
“although on the surface this trial seems to be quite beneficial to
patients[experiencing] Generalized Anxiety Disorder (GAD), I see some potential
issues.”
Dr. Porterfield highlighted
the sample size and trial duration, saying, “the trial was a very small group
for a very short duration (198 participants and only four weeks long).”
In addition, Dr.
Porterfield noted there was also improvement for patients who were part of the
placebo group (31% compared to 78% in the active group).”
Considering this, it’s
reasonable to infer that some of the favorable outcomes could be attributed to
a placebo-like response. Further studies will need to be completed to assess
the actual effectiveness of the medication.
Dr. Karlin told MNT that
“MindMed has evaluated the effects of MM-120 in study participants through 12
weeks post-dosing and are currently awaiting those data.”
“We expect to share [more]
of that data in the first quarter of 2024. We intend to present the full study
results at a scientific conference next year. MindMed also plans to hold an
‘End of Phase 2’ meeting with the FDA in the first half of 2024,” he said.
“Pending the outcome of
that meeting, we expect to initiate Phase 3 clinical trials in the second half of 2024,” he added.
Potential implications for future anxiety treatment
“Patients
and individuals impacted by GAD largely have been left behind in recent
decades; the last approval of a new GAD treatment came in 2004. The most widely
prescribed treatments for the disorder often fail to stimulate significant or
long-lasting improvement, while exposing patients to side effects that can
range from unpleasant to unbearable.”— Dr. Daniel Karlin
Dr. Karlin explained that
“the strong, rapid, and durable clinical activity observed following a single
dose of MM-120 is extremely promising for patients who are underserved by
current treatment options.”
“The data from this study
represents a major step forward in our goal to bring a paradigm-shifting
treatment to the millions of people impacted by this debilitating condition,”
he said.
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