Pasithea Therapeutics Announces Completion of GMP Manufacturing for PAS-004
June 29 2023 - 8:29AM
Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the
“Company”), a biotechnology company focused on the discovery,
research, and development of innovative treatments for central
nervous system (“CNS”) disorders, today announced it has
successfully completed manufacturing of GMP-compliant Phase 1
clinical supplies of the active pharmaceutical ingredient (“API”)
of its lead product candidate PAS-004, a next-generation
macrocyclic MEK Inhibitor.
GMP-compliant manufacturing of API was the final
step needed to support the Investigational New Drug (“IND”)
application that the Company expects to file with the U.S. Food and
Drug Administration (“FDA”) in the second half of 2023. The Company
intends to utilize this supply of PAS-004 for its upcoming Phase I
clinical trial.
Dr. Tiago Reis Marques, Pasithea’s Chief
Executive Officer, commented “We are pleased to have reached this
milestone efficiently and on time. We remain on track with our
development plan for PAS-004 and look forward to our IND
submission, which we intend to follow with the initiation of our
first-in-human Phase 1 clinical trial. Based on preclinical
testing, we believe that PAS-004 may differentiate in the clinic by
virtue of a PK profile enabling the potential for once a day
dosing. From our consultations with KOLs we believe a once a day
dosing regimen may become the preferred treatment option for
Neurofibromatosis type 1, or NF1.”
Dr. Graeme Currie, Pasithea’s Chief Development
Officer, stated “Pasithea acknowledges our exceptional partnership
with WuXi STA, a subsidiary of WuXi AppTec, for its chemistry,
manufacturing, and controls (CMC) services. We are grateful to WuXi
STA for its expertise throughout the process, development and
manufacturing of the API. The collaboration with WuXi STA has been
instrumental in enabling Pasithea to achieve this critical
milestone and we believe lays a strong foundation for the continued
development of PAS-004.”
Following the anticipated submission of the IND
application with the FDA, Pasithea plans to initiate a Phase 1
clinical trial in healthy volunteers by the end of 2023 with
clinical results, including pharmacokinetic, pharmacodynamic and
safety data, anticipated in the first half of 2024.
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 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 to support an IND application
with the FDA that we plan to submit in the second half of 2023.
Additionally, PAS-004 has received orphan-drug designation from the
FDA for the treatment of NF1.
About Pasithea Therapeutics
Corp.
Pasithea Therapeutics is a biotechnology company
primarily 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),
Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis
(MS).
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 the Company’s plans for filing an IND application with the
FDA, the initiation and anticipated results of a Phase 1 clinical
trial for PAS-004, and treatment options for Nerufibromatosis type
1, as well as other statements with respect to the Company’s plans,
assumptions, expectations, beliefs and objectives with respect to
product development, 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 timing of the
Company’s IND submission and planned clinical trials for PAS-004;
the ability of the Company’s clinical trials to demonstrate the
safety and efficacy and other positive results of PAS-004; and
other factors set forth in the Company’s most recent Form 10-K,
Form 10-Q 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
(SEC). 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.
ContactPatrick Gaynes Corporate
Communicationspgaynes@pasithea.com
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