Pasithea Therapeutics Announces Invention of Crystalline Form of PAS-004; Establishes Strengthened Intellectual Property (IP) Position
January 08 2024 - 7:59AM
Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the
“Company”), a clinical stage biotechnology company focused on
the discovery, research, and development of innovative treatments
for Central Nervous System (CNS) disorders, today announced the
invention of a crystalline form of PAS-004 which is captured in
polymorph and stereoisomer patent filings that when issued we
believe will extend patent protection to at least 2045.
Chief Development Officer Dr. Graeme Currie
stated, “Through the invention of the crystal structure for PAS-004
and subsequent patent filings, we are pleased to extend and
strengthen the PAS-004 patent portfolio which we believe extends
current protection from 2032 to at least 2045. We worked closely
with Jones Day, a top global law firm with a premier IP biotech
practice, to reach this important milestone.”
Chief Executive Officer Dr. Tiago Reis Marques
added, “Through additional chemistry, manufacturing, and controls
(CMC) development we believe that we continue to increase the value
of PAS-004. We are pleased that our upcoming phase 1 dose
escalation trial will utilize the newly invented crystalline drug
substance.”
About PAS-004
PAS-004 is a small molecule allosteric inhibitor
of MEK 1/2, which are dual-specificity protein kinases, in the MAPK
signaling pathway. The MAPK pathway has been implicated in a
variety of diseases, as it functions to drive cell proliferation,
differentiation, survival and a variety of other cellular functions
that, when abnormally activated, are critical for the formation and
progression of tumors, fibrosis and other diseases. MEK inhibitors
block phosphorylation (activation) of extracellular
signal-regulated kinases (ERK). Blocking the phosphorylation of ERK
can lead to cell death and inhibition of tumor growth. Existing FDA
approved MEK inhibitors are marketed for a range of diseases,
including certain cancers and neurofibromatosis type 1 (NF1). We
believe these MEK inhibitors suffer from certain limitations,
including known toxicities. Unlike current FDA approved MEK
inhibitors, PAS-004 is macrocyclic, which we believe may lead to
improved pharmacokinetic and safety (tolerability) profiles.
Cyclization offers rigidity for stronger binding with drug target
receptors. PAS-004 was designed to provide a longer half-life with
what we believe is a better therapeutic window. Further, we believe
the potency and safety profile that PAS-004 has demonstrated in
preclinical studies may also lead to stronger and more durable
response rates and efficacy, as well as better dosing
schedules. PAS-004 has been tested in a range of mouse models
of various diseases and has completed preclinical testing and
animal toxicology studies. Additionally, PAS-004 has received
orphan-drug designation from the FDA for the treatment of NF1.
About Pasithea Therapeutics
Corp.
Pasithea is a biotechnology company focused on
the discovery, research and development of innovative treatments
for central nervous system (CNS) disorders and RASopathies. With an
experienced team of experts in the fields of neuroscience,
translational medicine, and drug development, Pasithea is
developing new molecular entities for the treatment of neurological
disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors,
and Amyotrophic Lateral Sclerosis (ALS).
Forward Looking Statements
This press release contains statements that
constitute “forward-looking statements” made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements include all statements,
other than statements of historical fact, regarding the Company’s
current views and assumptions with respect to future events
regarding its business, including, without limitation, statements
about PAS-004, including the Company’s ability to increase its
value and to extend its patent protection, as well as other
statements with respect to the Company’s plans, assumptions,
expectations, beliefs and objectives, the success of the Company’s
current and future business strategies, product development,
preclinical and clinical studies, clinical and regulatory
timelines, market opportunity, competitive position, business
strategies, potential growth opportunities and other statements
that are predictive in nature. Forward-looking statements are
subject to numerous conditions, many of which are beyond the
control of the Company. While the Company believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to the Company on the date of this
release. These forward-looking statements are based upon current
estimates and assumptions and are subject to various risks and
uncertainties, including, without limitation, the Company’s ability
to increase the value of PAS-004 and to extend its patent
protection, and other factors set forth in the Company’s most
recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q
and other filings made with the U.S. Securities and Exchange
Commission. Thus, actual results could be materially different. The
Company undertakes no obligation to update these statements whether
as a result of new information, future events or otherwise, after
the date of this release, except as required by law.
Pasithea Therapeutics
Contact
Patrick GaynesCorporate Communicationspgaynes@pasithea.com
Pasithea Therapeutics (NASDAQ:KTTA)
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