– New Chemical Entity Aims to Provide New
Treatments for Refractory Depression and Depression with Suicidal
Thoughts –
– Ketamir-2 Is Being Developed As a Take Home
Alternative to The Revolutionary Drug Spravato, Which Must be Dosed
Under Medical Observation –
BALTIMORE,
Nov. 20,
2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc.
(NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative
pre-clinical-stage pharmaceutical company, today announced a
partnership with MIRALOGX, LLC, an intellectual property holding
company established by MIRA's founder. Under an exclusive licensing
agreement, MIRA will have the exclusive right in the U.S.,
Canada, and Mexico to develop and commercialize Ketamir-2,
a novel oral ketamine analog designed to revolutionize the
landscape of depressive disorder treatments. This transformative
collaboration includes a a $3 million
line of credit extended by MIRALOGX to fund the initial development
of Ketamir-2.
Ketamir-2 is a unique patent-pending compound is
under investigation to potentially deliver ultra-rapid
antidepressant effects as early as four hours after dosing,
providing hope for individuals battling treatment-resistant
depression (TRD) and major depressive disorder with suicidal
ideation (MDSI). Because of its potential for misuse or illegal
distribution, Ketamine is classified by the U.S. Drug Enforcement
Administration (DEA) as a Schedule III substance, meaning that it
is available legally only through a prescription, and its
distribution and use are closely monitored. In contrast, after
making its scientific review of Ketamir-2, the DEA concluded that
Ketamir-2 is not a controlled substance or listed chemical under
the Controlled Substances Act (CSA) and its governing
regulations.
Dr. Adam Kaplin,
MD, PhD, MIRA's President and Chief Scientific Officer and an
esteemed expert in ketamine research and an adjunct faculty member
at Johns Hopkins Medicine, will lead the development of Ketamir-2.
Dr. Kaplin served as the Johns Hopkins
site Principal Investigator for multi-center pivotal clinical
trials, leading to the approval of an intranasal left-handed
ketamine molecule called esketamine, brand name
Spravato®1. He also founded and managed the Johns
Hopkins Esketamine Clinic for Depression and made significant
contributions as Co-Chair to the National Network of Depression
Centers' Task Force on Ketamine for Depression.
Dr. Kaplin remarked, "In our continuing pursuit
to alleviate the burden of treatment-resistant depression, the
development of Ketamir-2 offers a promising beacon of hope. I am
honored to lead its development journey and am optimistic about its
potential to transform the lives of individuals suffering from TRD
and suicidal depression."
"A salient feature of Ketamir-2 is its potential
superior bioavailability as suggested by recent pre-clinical
studies. Unlike Ketamine, which necessitates intravenous,
intramuscular, or intranasal administration due to its limited oral
bioavailability, in initial pre-clinical studies, Ketamir-2 appears
to exhibit a more clinically desirable gastrointestinal absorption
profile. In addition, Ketamir-2's targeted design removes its
interaction with some of the receptors targeted by ketamine,
such as the opiate receptor, which are believed to be key to
mediating some of its key side effects, thus, potentially enhancing
Ketamir-2's safety and tolerability profile.. By focusing on such
receptors, Ketamir-2 is designed to possibly mitigate prevalent
side effects such as sedation, addiction, dissociative symptoms,
and cardiovascular concerns. Unlike Spravato, which must be
monitored during treatment for two hours by trained clinicians, we
believe that Ketamir-2's initial predicted favorable side effect
profile and its oral availability may pave the way for Ketamir-2's
target to achieve FDA approval for convenient home
self-administration, a significant boon for patient-centric
care."
Erez Aminov, Chief
Executive Officer of MIRA, added: "This partnership with MIRALOGX
is a testament to the shared vision of both companies in
transforming lives and driving mental health research. Ketamir-2
embodies hope, and this partnership propels us toward a future
where we may be able to actively address mental health challenges
with transformative solutions. Concurrently, our unwavering
commitment to the progress and development of MIRA1a remains
steadfast. We are strategically positioning both MIRA1a and
Ketamir-2 to maximize their impacts on advancing the treatment of
mental illness while broadening and diversifying MIRA's pipeline.
The combination of this exclusive licensing agreement and obtaining
initial funding for development through the MIRALOGX line of credit
propels MIRA into an exciting phase of innovation and
development."
About MIRALOGX, LLC
MIRALOGX LLC stands as a forefront developer,
pioneering the creation of novel molecular entities to address
unmet needs in healthcare. As a leading innovator, they are
committed to advancing the field by introducing groundbreaking
solutions that cater to unaddressed medical challenges.
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a
pre-clinical-stage pharmaceutical development company developing an
unscheduled novel synthetic THC analog. This novel compound is
currently under investigation for treating adult patients suffering
from anxiety and cognitive decline, often associated with
early-stage dementia. MIRA1a, if approved by the FDA, could mark a
significant advancement in addressing various neuropsychiatric,
inflammatory, and neurologic diseases and disorders. Based on
pre-clinical and animal studies conducted by the Company, the
Company believes that MIRA1a may enhance the therapeutic potential
for treating anxiety, cognitive decline, and neuropathic pain
without the side effects of plant-based THC. Furthermore, the
Company's studies show that MIRA1a may counteract the adverse
cognitive effects often seen with THC, thereby potentially
unmasking previously unseen positive therapeutic effects, such as
cognitive performance enhancement.
The U.S. Drug Enforcement Administration (DEA)'s
scientific review of MIRA1a concluded that MIRA1a would not be
considered a controlled substance or listed chemical under the
Controlled Substances Act (CSA) and its governing regulations or
require scheduling during development.
Additional information about the Company is
available at: www.mirapharmaceuticals.com.
Forward-Looking Statements
This press release may contain forward-looking
statements about MIRA Pharmaceuticals, Inc. ("MIRA," "we," "us," or
"our"). In some cases, you can identify forward-looking statements
by terminology such as "anticipate,' "believe," "contemplate,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "will" or
"would," or the negative of these terms or other comparable
terminology. These forward-looking statements are subject to
numerous risks and uncertainties, many of which are beyond our
control, including risks and uncertainties regarding our ability to
develop and obtain regulatory approval for our product candidates,
Ketamir-2 and MIRA1a. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors,
which may cause our actual results, levels of activity, performance
or achievements of and those of our industry to be materially
different from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. Some of these risks and uncertainties are identified in
our Registration Statement on Form S-1 filed with the SEC (File No.
333-273024) and in our other filings with the SEC, which are
available at www.sec.gov. You should not place undue reliance on
any forward-looking statement. We undertake no obligation to update
or revise publicly any of the forward-looking statements after the
date hereof to conform the statements to actual results or changed
expectations except as required by law.
General Note
This press release discusses product candidates
that are in early stage pre-clinical development and have not yet
been approved for marketing by the U.S. Food and Drug
Administration. No representations are made as to the safety or
effectiveness of these product candidates for the uses for which
they are being studied. There is no assurance that either product
candidate will proceed through development or will receive FDA
approval for marketing.
1 Spravato® is a
registered trademark of Janssen Pharmaceuticals, Inc.
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SOURCE MIRA Pharmaceuticals, Inc.