New preclinical studies suggest that, unlike
traditional ketamine, MIRA's oral ketamine analog Ketamir-2 does
not induce hyper-locomotor activity, indicative of psychotic
symptoms, offering the potential for safer mental health
treatments
MIAMI, June 24,
2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc.
(NASDAQ: MIRA) ("MIRA" or the "Company"), a leading
pre-clinical-stage pharmaceutical company focused on the treatment
of neurologic and neuropsychiatric disorders, today announced new
compelling preclinical results for its investigational compound,
Ketamir-2, a novel oral ketamine analog. The new data highlights
Ketamir's potential to provide therapeutic benefits without
inducing schizophrenia-like behavior or hyper-locomotor
activity.
These results follow the release of positive preclinical
efficacy data for Ketamir-2 earlier in June, which collectively are
forming the basis of an Investigational New Drug Application (IND)
that MIRA plans to submit to the U.S. Food and Drug Administration
(FDA) for Ketamir-2 by the end of this year.
Background on the Current Preclinical Study
MIRA conducted the latest rigorous preclinical studies in
collaboration with Biotrial to evaluate the effects of Ketamir-2 on
spontaneous locomotor activity in mice. The studies are
particularly significant for the treatment of mental health
disorders and pain management, presenting a major advancement in
the development of safer and more effective therapeutic
options.
Ketamine-induced hyperlocomotion is considered a
schizophrenia-like effect because it models the hyperactive and
psychotic symptoms observed in schizophrenia patients. The
hyperlocomotion induced by traditional ketamine is mediated by
increased dopamine release and turnover in the nucleus accumbens, a
brain region implicated in the positive symptoms of schizophrenia,
such as psychosis. Antipsychotic drugs like haloperidol,
which block dopamine receptors, can reduce the effect of
ketamine-induced hyperlocomotion, further linking this behavior to
the dopaminergic dysregulation hypothesized in schizophrenia.
Key Findings from the Study:
- Reduced Psychotic-like Symptoms: Unlike traditional
ketamine, which resulted in marked and significant hyperlocomotion,
Ketamir-2 did not produce incidences of inducing hyperlocomotion,
schizophrenia-like behaviors in animal models, indicating a
potentially safer profile for human patients, especially those with
a predisposition to psychotic disorders.
- No Hyper-locomotor Activity: The study showed that
while traditional ketamine induced hyperlocomotion, Ketamir-2, at
same and higher doses compared with traditional ketamine, did not
result in the hyper-locomotor activity, reducing the potential for
misuse and enhancing patient safety.
Implications for Patient Care and Market Potential:
Safety and Tolerability: By mitigating adverse effects
commonly linked with traditional ketamine, Ketamir-2 potentially
represents a significant leap forward in developing effective and
patient-friendly treatments for certain mental health disorders and
neuropathic pain. This improvement is crucial for long-term
patient compliance and overall treatment success.
Broader Therapeutic Applications: Ketamir-2's different
profile with enhanced safety features allows for its potential use
in a wider range of psychiatric and neurologic conditions,
expanding its applicability beyond current ketamine treatments.
This potentially positions Ketamir-2 as a versatile option in
the pharmaceutical landscape.
Economic Impact: With the financial burden of
treatment-resistant depression alone accounting for $43.8 billion annually in the U.S., Ketamir-2's
development could lead to substantial cost savings in healthcare by
providing a more efficient and safer treatment alternative.
Erez Aminov, Chairman & CEO
of MIRA Pharmaceuticals, stated, "Our latest findings on Ketamir-2
reinforce our commitment to addressing critical gaps in mental
health treatment. By offering a safer and more effective oral
alternative to traditional ketamine, we are paving the way for
groundbreaking advancements in patient care and treatment
outcomes."
Next Steps:
MIRA is on track to submit an IND application for Ketamir-2 to
the FDA by the end of this year. This submission will mark a
significant milestone in advancing Ketamir-2 toward clinical trials
and eventually making it available to patients in need.
Additionally, MIRA is conducting further safety and efficacy
studies on Ketamir-2 to further demonstrate its improved profile
compared to traditional ketamine. MIRA's commitment to
advancing research includes further studies on Ketamir-2 for cancer
pain and PTSD, aiming to provide effective and safe treatment
options for these challenging conditions.
Itzchak Angel, Ph.D., MIRA's
Chief Scientific Advisor, added, "The data we have obtained from
these studies is invaluable. They not only enhance our
understanding of Ketamir-2's pharmacological profile but also
underscore its potential benefits for patients with TRD and PTSD
and pave the way for what we believe will be straightforward
IND-enabling development."
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a
pre-clinical-stage pharmaceutical development company with two
neuroscience programs targeting a broad range of neurologic and
neuropsychiatric disorders. MIRA holds the exclusive U.S.,
Canadian, and Mexican rights for Ketamir-2, a novel,
patent-pending oral ketamine analog under investigation to
potentially deliver ultra-rapid antidepressant effects, providing
hope for individuals battling treatment-resistant depression, major
depressive disorder with suicidal ideation, and post-traumatic
stress disorder.
In addition, MIRA's novel oral pharmaceutical marijuana analog,
MIRA-55, is currently under investigation for
treating adult patients suffering from neuropathic pain as well as
anxiety and cognitive decline, often associated with early-stage
dementia. MIRA-55, if approved by the FDA, could mark a significant
advancement in addressing various neuropsychiatric, inflammatory,
and neurologic diseases and disorders.
The U.S. Drug Enforcement Administration's scientific review of
Ketamir-2 and MIRA-55 concluded that each would not be considered a
controlled substance or listed chemical under the Controlled
Substances Act and its governing regulations. These
conclusions remove potential complications for manufacturing,
pre-clinical development, IND submission, clinical development, and
commercialization of these drug candidates.
For more information, visit www.mirapharmaceuticals.com.
Ketamir-2 and MIRA-55 are in early-stage preclinical
development. There is no assurance that the products will proceed
through development or will receive FDA approval for
marketing.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements," which
are statements other than historical facts made pursuant to the
safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. These statements may be identified by words such
as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans,"
"possible," "potential," "seeks," "will," and variations of these
words or similar expressions. Any statements in this press release
that are not historical facts may be deemed forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding the anticipated benefits of the
study results described herein, Ketamir's potential in treating
certain mental health conditions, and the timing for further
preclinical and clinical studies and FDA submissions.
Forward-looking statements are based on the Company's current
expectations, estimates, and projections only as of the date of
this release and are subject to a number of risks and uncertainties
(many of which are beyond the Company's control) that could cause
actual results to differ materially from those set forth in or
implied by such forward-looking statements. These and other risks
concerning the Company's programs and operations are described in
detail in the Annual Report on Form 10-K for the year ended
December 31, 2023, and other SEC
filings, available at www.sec.gov and the Company's website at
www.mirapharmaceuticals.com/investors/sec-filings. The Company
explicitly disclaims any obligation to update any forward-looking
statements except as required by law.
View original
content:https://www.prnewswire.com/news-releases/mira-pharmaceuticals-announces-ketamir-2-shows-promising-safety-profile-in-comparison-to-traditional-ketamine-in-preclinical-testing-302179730.html
SOURCE MIRA Pharmaceuticals, Inc.