New Data from IQVIA Supports Potential
$3 Billion Annual Market
BALTIMORE, Nov. 29,
2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc.
(NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative
pre-clinical-stage pharmaceutical company focused on neurologic
diseases and neuropsychiatric disorders, today announced results
from recent studies that indicate Ketamir-2's oral bioavailability
is predicted to be approximately 80%.
MIRA recently unveiled its revolutionary product, Ketamir-2,
which is designed to potentially reshape the landscape of
depression treatment.
Ketamir-2 lead developer Adam
Kaplin, MD, Ph.D., President and Chief Scientific Officer of
MIRA Pharmaceuticals, commented: "Ketamir-2, an innovative analog
of Ketamine developed as an oral formulation, signifies a
breakthrough for Major Depressive Disorder and MDSI. 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."
Recent laboratory invitro studies of the CaCO-2 model of human
intestinal drug absorption suggested Ketamir-2's superior
absorption when taken by mouth compared to Ketamine, with key
findings indicating a dramatic 41% net absorption (amount of drug
absorbed minus the amount pumped back into the gut), signifying
significantly improved uptake compared to Ketamine's -15% (where
the amount of drug pumped back into the gut from the bloodstream,
for eventual excretion, exceeded the amount absorbed into the
body).
Given oral Ketamine's previously determined 23% bioavailability
when taken by mouth, Ketamir-2's adjusted oral bioavailability
based on the CaCO-2 results is predicted to be around
80%1. This bioavailability is more than double that
of oral or intranasal absorption of ketamine, promising a potential
shift to oral, home administration, granting patients greater
autonomy, convenience, and accessibility to effective depression
treatment.
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-2 could generate an average annual sales of
$3 billion, with estimates rising to
up to $7.8 billion. This projection
highlights Ketamir-2's potential to bridge the therapeutic gap
experienced by 30% of patients who do not find relief from
conventional treatment-resistant depression (TRD) and major
depressive disorder with suicidal ideation (MDSI) treatments,
solidifying its status as a trailblazing therapeutic agent.
"This positive financial outlook bolsters our confidence in
advancing Ketamir-2's clinical development," said Erez Aminov, Chief Executive Officer of MIRA
Pharmaceuticals. "We are poised to make a significant impact to a
market that urgently needs innovative solutions."
Annupama Kumar, MBBS, Vice President of Drug Development at MIRA
Pharmaceuticals, added: "Oral delivery of Ketamir-2 could transform
depression management, offering more consistent and accessible
treatment for patients. This advancement is not just a milestone
for MIRA Pharmaceuticals, but a beacon of hope for millions
battling severe depression."
Ongoing research aims to confirm these findings and establish
the safety and efficacy of Ketamir-2's oral administration.
With a keen focus on patient well-being and a robust pipeline,
MIRA Pharmaceuticals is leading the way to a brighter future for
individuals battling severe depression.
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
diseases 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.
About IQVIA Holdings Inc.
IQVIA Holdings Inc. is a leading global provider of advanced
analytics, technology solutions, and clinical research services to
the life sciences industry. The Company sought the expertise of
IQVIA and commissioned them to conduct an in-depth analysis of its
Ketamir-2 asset.
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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1 Zhang
K, Yao Y, Hashimoto K. Ketamine and its metabolites: Potential as
novel treatments for depression. Neuropharmacology. Jan 1
2023;222:109305. doi:10.1016/j.neuropharm.2022.109305
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SOURCE MIRA Pharmaceuticals, Inc.