Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004
February 13 2024 - 7:59AM
Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the
“Company”), a clinical-stage biotechnology company developing
PAS-004, a next-generation macrocyclic MEK inhibitor, for the
treatment of neurofibromatosis type 1 (NF1) and other cancer
indications, today announced the activation of four clinical trial
sites in the United States. These U.S. clinical trial sites in
Texas and Virginia are now open and actively enrolling patients.
This announcement follows the approval from the
U.S. Food and Drug Administration (FDA) of the Investigational New
Drug (IND) application for PAS-004, and FDA review of the protocol
for the Company’s Phase 1 multicenter, open-label trial of PAS-004
in patients with MAPK pathway-driven advanced solid tumors with a
documented RAS, NF1 or RAF mutation or patients who have failed
BRAF/MEK inhibition.
The objective of the Phase 1 study is to assess
the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) of PAS-004 as well as to evaluate the
preliminary anticancer activity (efficacy) of PAS-004 and to define
the preliminary recommended Phase 2 dose.
The Company's clinical development plan for
PAS-004 following the Phase 1 study is to begin a Phase 2 clinical
trial in NF1 pediatric and adult patients as soon as safety and PK
are established.
Pasithea has selected Novotech as the clinical
research organization (CRO) for the Phase 1 trial and will be
collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony
Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as
principal investigator for the San Antonio, TX site. There are also
three other clinical trial sites in Eastern Europe that are
expected to open in the coming months.
“Activating our four clinical trial sites in the
U.S. is a significant milestone in Pasithea’s mission towards
developing PAS-004 as a potential best-in-class next-generation MEK
inhibitor. We recognize the significant unmet needs and limited
treatment options for patients with MAPK pathway-driven advanced
solid tumors as well as NF1. We are ready to screen and enroll
subjects in the coming month and look forward to gaining insight
into the safety, tolerability and initial efficacy of PAS-004.”
said Dr. Tiago Reis Marques, Chief Executive Officer of
Pasithea.
PAS-004 is the first macrocyclic MEK inhibitor
to enter human clinical trials, with an expected extended half-life
in humans which may provide better compliance rates as well as
improved efficacy in NF1. Macrocycles are known to exhibit stronger
binding, better solubility and longer half-life with more
selectivity and less off target effect as compared to acyclic small
molecules.
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), which 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, which may provide seven years of marketing exclusivity upon
approval of an NDA.
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 other diseases. 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, 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 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
forward-looking 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
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