Ketamir-2 is a potential treatment for certain
major mental health disorders impacting millions of people
in the U.S.
MIAMI, April 2,
2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc.
(NASDAQ: MIRA) ("MIRA" or the "Company"), a
pre-clinical-stage pharmaceutical company focused on the treatment
of neurologic and neuropsychiatric disorders, today
shares updates on the ongoing pre-clinical studies of its
investigational compound, Ketamir-2, a novel oral ketamine analog
which could potentially deliver ultra-rapid antidepressant
effects.
MIRA is conducting pre-clinical studies of Ketamir-2 in
collaboration with Frontage Laboratories as a potential
treatment for individuals battling treatment-resistant depression
(TRD), major depressive disorder with suicidal ideation (MDSI) and
post-traumatic stress disorder (PTSD). MIRA is hopeful that
the encouraging results of these most recent studies will enable
MIRA to file an Investigational New Drug Application (IND) with the
U.S. Food and Drug Administration by the end of this year which, if
accepted, would allow for human testing of Ketamir-2.
The latest in vitro research focused on Ketamir-2's stability in
the bloodstream, its metabolism (processing by the body), and how
it binds to proteins in the blood. These factors play a
crucial role in determining a drug's adequacy and likelihood for
acceptable safety, its pharmacological profile and potential modes
of administration to patients.
- Blood Stability and Distribution: Ketamir-2
demonstrated excellent stability in blood from various species,
including humans. This means that once in the bloodstream,
Ketamir-2 remains unchanged for a sufficient duration, allowing it
to potentially exert its therapeutic effects effectively.
- Metabolic Profile: The studies indicate the
potential for Ketamir-2 to be metabolized effectively and safely.
The clear identification of specific liver enzymes hints at
the potential for Ketamir-2 having fewer interactions with other
medications, addressing a common concern among doctors and
patients.
- Protein Binding: Ketamir-2 appears to bind
optimally to blood proteins, which suggests the potential for
effective delivery throughout the body. This property is
crucial for distributing the drug to brain areas where it can exert
its effects.
- Safety Profiles: Initial toxicology assessments
provide a favorable safety profile crucial for advancement through
regulatory review and clinical trials.
Erez Aminov, Chairman & CEO
of Mira Pharmaceuticals, shared, "The financial impact of
medication-treated major depressive disorder in the U.S. stands at
an overwhelming $92.7 billion
annually, with $43.8 billion
(47.2%) of this amount due to treatment-resistant
depression1. Additionally, the U.S. market for
post-traumatic stress disorder treatments is on a significant rise,
projected to reach $26 billion by
20312. In short, we are facing a mental health
crisis in the U.S., and at MIRA Pharmaceuticals, we are developing
Ketamir-2 to address these substantial market and medical needs."
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 but also
underscore its potential benefits for patients with TRD and PTSD
and pave the way for what we believe will be straight forward
IND-enabling development."
1 The Journal of Clinical Psychiatry, PMID:
33989464
2 Allied Market Research: Post-Traumatic Stress
Disorder Treatment Market Research, 2031
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. The U.S. Drug
Enforcement Administration's scientific review of Ketamir-2
concluded that it would not be considered a controlled substance or
listed chemical under the Controlled Substances Act and its
governing regulations.
In addition, MIRA's novel oral pharmaceutical marijuana,
MIRA-55, is currently under investigation for
treating adult patients suffering from 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.
Additional information about the Company is available
at: www.mirapharmaceuticals.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of the Company's
management related thereto 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 that are intended to identify
forward-looking statements. Any statements in this press
release that are not historical facts may be deemed
forward-looking. These forward-looking statements include, without
limitation, statements regarding Ketamir-2's potential in treating
certain mental health conditions. Any forward-looking
statements in this press release 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 (including the anticipated benefits of the Company's
pre-clinical testing and pre-clinical data discussed herein) to
differ materially and adversely 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
additional detail in Annual Report on Form 10-K for the year ended
December 31, 2023 and other SEC
filings, which are on file with the SEC at www.sec.gov and the
Company's website at
https://www.mirapharmaceuticals.com/investors/sec-filings. The
Company explicitly disclaims any obligation to update any
forward-looking statements except to the extent required by
law.
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SOURCE MIRA Pharmaceuticals, Inc.