The positive results from this preclinical study
underscore Ketamir-2's potential as a superior alternative to
traditional ketamine
Unlike ketamine, which requires intravenous or
intranasal administration, Ketamir-2's oral formulation promises
ease of use and better patient compliance and is not a controlled
substance under DEA rules
MIAMI, June 10,
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 announced positive preclinical
study results highlighting the potential efficacy and safety
profile of Ketamir-2, MIRA's novel oral ketamine analog
designed to treat depression and treatment-resistant depression
(TRD).
Mira Announces Positive Preclinical Study
Results For Its Novel Oral ketamine Analog, Ketamir-2
The highly encouraging study results further MIRA's goal of
submitting an Investigational New Drug Application (IND) to the
U.S. Food and Drug Administration (FDA) later this year which, if
granted, would allow for human clinical trials of Ketamir-2.
Key Findings from the Study
The study, conducted by Pharmaseed Ltd., evaluated the
anti-depressive and anxiolytic effects of oral Ketamir-2, in
comparison with oral ketamine, using established behavioral tests
in male mice. The tests included the Open Field Test (OFT),
Elevated Plus Maze (EPM), and Forced Swim Test (FST). Under
the experimental conditions of these studies, it was possible to
use 10 fold-higher oral doses of Ketamir-2, compared with ketamine,
which induced major sedative and other side effects already at low
doses.
The following findings were observed:
- Open Field Test (OFT)
- Mice treated with Ketamir-2 showed dose-related, significantly
greater locomotor activity, higher travel speed and a trend towards
an increased time spent in the center of the arena, indicating
reduced anxiety levels.
- Elevated Plus Maze (EPM)
- In this model of depression, significant increases in travel
distance and speed were observed in mice treated with Ketamir-2.
Furthermore, Ketamir-2 treated mice spent more time in the open
arms of the maze, suggesting reduced anxiety.
- Forced Swim Test (FST)
- In this model of depression and anxiety, mice in the Ketamir-2
treated arm demonstrated reduced swimming distances and speed,
indicating reduced behavioral despair and anti-depressant
effect.
- In addition, Ketamir-2 treatment resulted in significantly
reduced immobility times, highlighting its potential antidepressant
properties.
Traditional ketamine was used as a positive control in this
study. In many of the above parameters, traditional ketamine
given orally at the highest dose feasible was inactive, again
pointing to the comparative potential benefits of Ketamir-2, which
is designed to be delivered orally.
Clinical Implications and Future Directions
The positive results from this preclinical study underscore
Ketamir-2's potential as a superior alternative to traditional
ketamine. Ongoing studies with third-party research
organizations Pharmaseed and Biotrial are evaluating Ketamir-2's
efficacy in treating post-traumatic stress syndrome and neuropathic
pain, as well as conducting further safety studies in comparison to
ketamine.
"We are thrilled with the promising results from these
preclinical trials, which demonstrate Ketamir-2's efficacy and
improved safety profile over traditional ketamine," said
Erez Aminov, Chairman & CEO of
Mira Pharmaceuticals. "These findings represent a significant
milestone as we prepare for an IND submission to the FDA later this
year. We are hopeful that Ketamir-2 will offer a new, safe and
orally effective treatment option for patients suffering from
depression and TRD."
Dr. Itzchak Angel, Chief
Scientific Advisor of Mira Pharmaceuticals, added, "The data
generated from these studies will be invaluable in demonstrating
Ketamir-2's potential benefits. Its demonstrated activity by the
oral route, its pharmacological profile and lack of unwanted
side-effects make Ketamir-2 a potentially safer and more effective
option for treating depression in a home setting."
About MIRA Pharmaceuticals
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 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 MIRA-55 concluded that it
would not be considered a controlled substance or listed chemical
under the Controlled Substances Act and its governing regulations.
Additional information about the Company is available at:
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 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 the anticipated benefits of the
study results described herein as well as the timing for the
Company's other preclinical studies and the filing of an IND for
Ketamir-2. 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 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.