MindMed Announces Issuance of New Patent for MM120 Orally Disintegrating Tablet (ODT)
2024年7月17日 - 8:00PM
ビジネスワイヤ(英語)
- New patent covers MM120 ODT formulation and
extends patent term to 2041-
- Claims include pharmaceutical formulation,
methods of manufacturing and methods of treatment for MM120
ODT-
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or
“MindMed”), a clinical stage biopharmaceutical company developing
novel product candidates to treat mental health disorders, today
announced the issuance of a new patent by the United States Patent
and Trademark Office (USPTO) covering MM120 (lysergide). MM120 is
currently in clinical development for adults with generalized
anxiety disorder (GAD) and presents opportunities for treating a
range of additional brain health disorders.
The newly issued patent (USPN 12,036,220) includes claims
covering the pharmaceutical formulation, methods of manufacturing
and method of treatment for MM120 ODT, MindMed’s proprietary and
pharmaceutically optimized form of lysergide (LSD). The
pharmaceutical formulation patent is the first US patent issued on
the MM120 ODT formulation and extends the Company’s intellectual
property protection for MM120 through 2041.
This advanced formulation incorporates Catalent’s Zydis® ODT
fast-dissolve technology, which the Company believes will deliver
substantial pharmacological advantages for MM120 and a unique
clinical profile with more rapid absorption, improved
bioavailability and reduced gastrointestinal side effects. MindMed
holds exclusive rights to the Zydis technology for all salt and
polymorphic forms of lysergide for pharmaceutical usage for the
treatment of human disease and disorders in the United States, the
United Kingdom, the European Union, Switzerland, Israel, and
Canada.
“We have adopted an effective, multi-pronged strategy to protect
MM120 and its potential uses across a number of large therapeutic
indications like GAD and other brain health disorders,” said Rob
Barrow, Chief Executive Officer of MindMed. “The issuance of this
patent extends our IP protection for MM120 to at least 2041 and,
more importantly, covers the unique properties of our MM120 ODT
formulation. These clinical features underscore our dedication to
creating treatments that are effective and optimize the patient's
experience. Our PK bridging study reported earlier this year
demonstrated these advantageous properties and support this
formulation’s use in our Phase 3 clinical trials, and, if
ultimately approved, for clinical use.”
About MM120
MM120 (LSD or lysergide D-tartrate) is a synthetic ergotamine
belonging to the group of classic, or serotonergic, psychedelics,
which acts as a partial agonist at human serotonin-2A
(5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing
MM120, the tartrate salt form of lysergide, for GAD and is
exploring its potential applications in other serious brain health
disorders. Based on the significant unmet medical need in the
treatment of GAD – especially in patients who do not respond to or
tolerate currently available medications – along with the initial
clinical data from Phase 2b and other research conducted by
MindMed, the U.S. Food & Drug Administration (FDA) has
designated MM120 for GAD as a breakthrough therapy. MM120 is
entering Phase 3 clinical trials in the second half of 2024 in GAD
with additional clinical indications under exploration.
About Generalized Anxiety Disorder (GAD)
GAD is a common condition associated with significant impairment
that adversely affects millions of people. GAD results in fear,
persistent anxiety, and a constant feeling of being overwhelmed. It
is characterized by excessive, persistent, and unrealistic worry
about everyday things. Approximately 10% of U.S. adults,
representing around 20 million people, currently suffer from GAD.
This underdiagnosed and underserved indication is associated with
significant impairment, less accomplishment at work and reduced
labor force participation. Despite the significant personal and
societal burden of GAD, there has been little innovation in the
treatment of GAD in the past several decades, with the last new
drug approval occurring in 2007.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel product candidates to treat brain health disorders. Our
mission is to be the global leader in the development and delivery
of treatments that unlock new opportunities to improve patient
outcomes. We are developing a pipeline of innovative product
candidates, with and without acute perceptual effects, targeting
neurotransmitter pathways that play key roles in brain health
disorders. MindMed trades on NASDAQ under the symbol MNMD.
Forward-Looking Statements
Certain statements in this news release related to the Company
constitute “forward-looking information” within the meaning of
applicable securities laws and are prospective in nature.
Forward-looking information is not based on historical facts, but
rather on current expectations and projections about future events
and are therefore subject to risks and uncertainties which could
cause actual results to differ materially from the future results
expressed or implied by the forward-looking statements. These
statements generally can be identified by the use of
forward-looking words such as “will”, “may”, “should”, “could”,
“intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”,
“potential” or “continue”, or the negative thereof or similar
variations. Forward-looking information in this news release
includes, but is not limited to, statements regarding timing of the
initiation of a potential Phase 3 clinical trial of MM120, the
potential benefits of the Zydis ODT fast-dissolve technology and
the potential benefits of the Company’s product candidates. There
can be no guarantees regarding the timing or results of the
potential Phase 3 clinical trials for MM120 for the treatment of
GAD or that, following any such trials, MM120 will receive the
necessary regulatory approvals. There are numerous risks and
uncertainties that could cause actual results and the Company’s
plans and objectives to differ materially from those expressed in
the forward-looking information, including its history of negative
cash flows; limited operating history; incurrence of future losses;
availability of additional capital; lack of product revenue;
compliance with laws and regulations; difficulty associated with
research and development; risks associated with clinical trials or
studies; heightened regulatory scrutiny; early stage product
development; clinical trial risks; regulatory approval processes;
novelty of the psychedelic inspired medicines industry; as well as
those risk factors discussed or referred to herein and the risks
described in the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, under headings such as
“Special Note Regarding Forward-Looking Statements,” “Risk Factors”
and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations,” and other filings and furnishings made
by the Company with the securities regulatory authorities in all
provinces and territories of Canada which are available under the
Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S.
Securities and Exchange Commission on EDGAR at www.sec.gov. Except
as required by law, the Company undertakes no duty or obligation to
update any forward-looking statements contained in this release as
a result of new information, future events, changes in expectations
or otherwise.
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から 7 2023 まで 7 2024