Announces Research Collaboration with
Pharmaseed to Conduct Pre-Clinical Studies on the Use of Ketamir
for Patients with Major Depressive Disorder (MDD) and
Post-Traumatic Stress Disorder (PTSD)
Studies will Investigate Antidepressant
Properties of Ketamir to Position for Initial IND Application in
2024
BALTIMORE, Feb. 5, 2024
/PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA)
("MIRA" or the "Company"), an innovative pre-clinical-stage
pharmaceutical company focused on the treatment of neurologic and
neuropsychiatric disorders, today provided a corporate and
operational update.
The Company has partnered with Pharmaseed Ltd., a clinical
research organization ("CRO"), to research and evaluate Ketamir-2
("Ketamir"), a novel ketamine analog with improved gastrointestinal
bioavailability under investigation to potentially be an orally
delivered ultra-rapid antidepressant.
Pharmaseed is Israel's largest
GLP-certified pre-clinical and early clinical CRO specializing in
translational and regenerative studies. The MIRA team will utilize
Pharmaseed's neurological disorder expertise to conduct
pre-clinical research on Ketamir, focusing primarily on
investigating its antidepressant properties. The studies will
include safety and efficacy evaluation in various animal models.
Additionally, MIRA has initiated a Toxicology program for Ketamir
in collaboration with Frontage Laboratories. The Company
anticipates positioning Ketamir for an initial Investigational New
Drug (IND) application with the FDA by the end of 2024.
Ketamir is a novel compound designed to address the challenges
presented by major depressive disorder (MDD), a significant health
concern affecting approximately 18 million people in the U.S., of
which 5.5 million reported suicide ideation (MDSI)1.
Tailored for convenient home use, it offers administration ease and
aims for fewer side effects, eliminating the need for clinical
supervision associated with existing treatments like Spravato. The
total annual burden of medication-treated MDD among the US
population was $92.7 billion, with
$43.8 billion (47.2%) attributable to
Treatment Resistant Depression (TRD)2.
Moreover, Ketamir is also under investigation for treating Post
Traumatic Stress Disorder (PTSD), a market that is projected to
reach $26 billion by
20313. Ketamir aims to serve as an alternative to
commonly prescribed drugs for PTSD including SSRIs such as
Sertraline (Zoloft), Paroxetine (Paxil), as well as SNRIs such as
Venlafaxine (Effexor).
Additionally, a valuation analysis conducted by IQVIA, a leading
global provider of advanced analytics, technology solutions, and
clinical research services to the life sciences industry, forecasts
that by 2035, Ketamir could generate average annual sales of
$3 billion, with estimates rising to
up to $7.8 billion4.
"We are privileged to be working with Pharmaseed to evaluate our
novel ketamine analog that may have the potential to transform the
treatment of depression and PTSD," said Erez Aminov, Chief Executive Officer of MIRA
Pharmaceuticals. "Pharmaseed is an ideal pre-clinical research
partner with their experience in a wide range of neurological
disorders including depression and anxiety. Results from recent
studies indicate Ketamir's oral bioavailability is predicted to be
approximately 80%, and this ongoing research aims to confirm these
findings and establish the safety and efficacy of Ketamir's oral
administration. We believe the pre-clinical program and toxicology
work will prepare us for an IND application investigating Ketamir
for the treatment of TRD, MDSI, and PTSD in late 2024, with a Phase
I trial expected to begin post-IND submission. With a growing need
for a rapid-acting antidepressant that can assist patients with
TRD, MDSI, and PTSD and strong market potential, we look forward to
the results from the partnership with Pharmaseed."
Itschak Lamensdorf, PhD, Founder
and CEO of Pharmaseed, added, "We're enthusiastic about joining
forces with MIRA to develop their groundbreaking pipeline for CNS
disorders, a field with critical unmet needs. At Pharmaseed,
leveraging our expertise to transition ideas into early clinical
stages is fundamental to our mission, and this collaboration is a
testament to that commitment."
New Research Coverage
MIRA is honored to announce that Kingswood Capital Partners,
LLC, a respected and reputable entity in the financial sector, has
initiated research coverage on the Company's publicly traded stock
with a Buy rating and a $10 Price
Target. For more information, please contact your Kingswood Capital
Partners, LLC representative.
About Pharmaseed Ltd.
Pharmaseed is a GLP-certified contract research organization
(CRO) providing pre-clinical, early clinical and consulting
services for medical device, biotechnology and pharmaceutical
companies. Pharmaseed also provides pre-formulation services for
small and medium-size start-up companies as well as companies in
the idea and feasibility stages. For more information, visit
https://www.pharmaseedltd.com/.
About Kingswood Capital Partners, LLC
Kingswood Capital Partners, LLC, part of the Kingswood Group, is
a network of wealth management firms that includes an
SEC-registered RIA and a FINRA-licensed broker-dealer, offering
comprehensive wealth management and business-building services,
designed specifically for the independent financial advisor.
1 BMC Psychiatry, PMID: 32703173
2 The Journal of Clinical Psychiatry, PMID:
33989464
3 Allied Market Research: Post-Traumatic Stress
Disorder Treatment Market Research, 2031
4 IQVIA Analysis
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. The Company's novel oral pharmaceutical
marijuana, MIRA1a, 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.
MIRA has an exclusive licensing agreement for Ketamir-2, a
unique, patent pending novel oral ketamine analog under
investigation to potentially deliver ultra-rapid antidepressant
effects, providing hope for individuals battling
treatment-resistant depression (TRD) and major depressive disorder
with suicidal ideation (MDSI).
The U.S. Drug Enforcement Administration (DEA)'s scientific
review of MIRA1a and Ketamir-2 concluded that neither would be
considered a controlled substance or listed chemical under the
Controlled Substances Act (CSA) and its governing regulations.
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.
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SOURCE MIRA Pharmaceuticals, Inc.