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 that it acquired
AlloMek Therapeutics, LLC (“AlloMek”), a privately-held
biotechnology company. AlloMek’s lead therapeutic candidate,
CIP-137401, is a potential best-in-class macrocyclic
mitogen-activated protein kinase kinase 1/2 (MEK) inhibitor for use
in a range of CNS-related indications, including neurofibromatosis
type 1 (NF1) and Noonan syndrome, as well as potential synergy with
our existing multiple sclerosis (MS) development program. The
closing of the acquisition occurred on October 11, 2022.
CIP-137401 is a small molecule allosteric
inhibitor of MEK 1/2, a key kinase in the Ras-Raf-MEK-ERK signaling
pathway. Existing MEK inhibitors are marketed for a range of
diseases, providing evidence for the value of regulating MEK as a
drug target, however, they suffer from limitations. Unlike other
MEK inhibitors, CIP-137401 is macrocyclic, which displays improved
drug-like properties, such as an optimal pharmacokinetic (PK),
safety (tolerability) and potency profile, offering potential
benefits over other MEK inhibitors. CIP-137401 was designed to
limit toxicities and overcome poor pharmacokinetic profiles such as
short half-lives and the formation of major metabolites, which
result in the limited exposure and stability of known MEK
inhibitors.
“The acquisition of AlloMek represents the
successful continuation of our business development strategy.
Expanding our CNS-focused drug development pipeline with near-term
clinical opportunities addressing rare RASopathies positions us for
long-term growth opportunities and potential synergies with our
existing tolerizing program, which we believe will yield the
greatest results for patients, the healthcare community and
stockholders,” stated Dr. Tiago Reis Marques, Chief Executive
Officer of Pasithea. “CIP-137401 was designed to impart optimum
drug-like properties potentially allowing for higher exposure,
improved efficacy and less frequent dosing which can drive better
outcomes as well as improved patient compliance to address issues
with existing MEK inhibitors. In addition, we would like to welcome
the venture capital firm Connecticut Innovation Fund (CI) to our
stockholder registry as a long term focused institutional
shareholder who has supported the development of CIP-137401.”
CIP-137401 has displayed efficacy in a range of
mouse models of various diseases and has completed pre-clinical
testing and animal toxicology studies to support an Investigational
New Drug (IND) application with the U.S. Food and Drug
Administration (FDA). CIP-137401 has already received orphan-drug
designation from the FDA for NF1. The Company plans to initially
focus clinical development of CIP-137401 on NF1 followed by Noonan
syndrome, both rare diseases with significant unmet clinical
needs.
Dr. Marques added, “We look forward to bringing
CIP-137401 into the clinic rapidly. We currently anticipate filing
an IND in the second half of 2023 following good manufacturing
practice (GMP) manufacturing of CIP-137401, which is needed for the
IND-submission, and initiation of human clinical trials. Our
clinical strategy is to pursue the development of CIP-137401 in NF1
followed by Noonan syndrome, which may offer the potential for a
rare pediatric disease priority review voucher (PRV) from the
FDA.”
Dr. Uday Khire, Chief Executive Officer of
AlloMek, noted, “We are excited to work with the esteemed team at
Pasithea to get CIP-137401 into patients. We strongly believe in
our lead molecule, CIP-137401, which has shown a unique combination
of potency, tolerability and PK profile in preclinical settings and
could prove to be a sweet spot among MEK inhibitors.”
“We have worked with the drug candidate in our
laboratory in a mouse model of a rare inherited heart disease with
increased cardiac ERK activity,” added Howard J. Worman, M.D.,
Professor of Medicine and Pathology and Cell Biology at Columbia
University and Chair of AlloMek’s Scientific Advisory Board. “In
our model, CIP-137401 was very effective in controlling cardiac
fibrosis, extremely potent in reducing tissue ERK activity in
vivo and well-tolerated by the animals.”
Lawrence Steinman MD, Professor of Neurology and
Neurological Sciences at Stanford University and Chairman of the
board of directors at Pasithea, concluded, “AlloMek’s programs are
potentially transformative for unmet needs in neurologic diseases,
including NF1 and Noonan syndrome and may synergize with Pasithea’s
program in MS. Pasithea has experimental data on tolerizing the
immune system to unwanted responses to a molecule called GlialCAM,
which is similar (molecular mimicry) to Epstein-Barr virus and to
members of the Poxvirus family. Published research in Nature showed
that kinases are critical for facilitating pathological
cross-reaction by adding phosphate residues (phosphorylation) to
key amino acids. CIP-137401 has the potential to block
phosphorylation of the molecular mimic, and by doing so, help to
ameliorate the pathology that triggers MS.”
Transaction Overview:
Pasithea acquired all of the issued and
outstanding equity interests in AlloMek in exchange for a $1.05
million upfront cash payment and the issuance of 2,700,000 shares
of restricted common stock plus 5-year warrants to acquire
1,000,000 shares of common stock at an exercise price of $1.88 per
share. Pasithea is also obligated to make certain clinical and
regulatory event-driven milestone payments, as well as low-to-mid
single digit escalating royalties on net sales.
For a more detailed description of the terms of
the AlloMek acquisition and the related definitive agreement,
please see the Company’s Current Report on Form 8-K to be filed
with the U.S. Securities and Exchange Commission.
Conference Call Information:
Pasithea will host a conference call and live
audio webcast today, October 12, 2022, at 9 a.m. ET, to discuss the
acquisition of AlloMek and provide a strategic outlook for the
Company. Interested participants and investors may access the
conference call by using the following URL.
-
https://event.choruscall.com/mediaframe/webcast.html?webcastid=lJsMuWAK
An audio webcast of the conference call will be
accessible via the Investors section of our website,
www.pasithea.com. An archive of the webcast will remain available
for 90 days following this event.
About CIP-137401
CIP-137401 is a small molecule allosteric
inhibitor of MEK 1/2 in the Ras-Raf-MEK-ERK signaling pathway,
which plays critical roles in the regulation of diverse cellular
activities, including cell proliferation, survival,
differentiation, and motility. Existing MEK inhibitors are marketed
and being tested for a range of diseases providing evidence for the
value of regulating MEK as a drug target, however they suffer from
limitations. Unlike other MEK inhibitors, CIP-137401 is
macrocyclic, which displays improved drug-like properties, such as
an optimal pharmacokinetic, safety (tolerability) and potency
profile, offering potential benefits over other MEK inhibitors.
Macrocycles are large cyclic molecules that can bring increased
potency, metabolic stability, and oral bioavailability. Cyclization
offers rigidity for stronger binding with drug target receptors.
CIP-137401 was developed to limit metabolic liabilities and
overcome the limited exposure and stability of known MEK
inhibitors. CIP-137401 has displayed efficacy in a range of animal
models and has completed pre-clinical testing and animal toxicology
studies to support an IND application with the FDA. CIP-137401has
received orphan-drug designation from the FDA for NF1.
About Neurofibromatosis
type 1
NF1 is part of a group of conditions known as
neurocutaneous disorders that affect the skin and the nervous
system. NF1 causes tumor growth along nerves in the skin, brain,
near the spinal cord and other parts of the body. These tumors are
usually benign (non-cancerous), however they cause a range of
symptoms with varying severity among affected people. People with
NF1 typically have problems with their bones, eyes and nervous
system, as well as other complications, including high blood
pressure, learning disabilities, attention deficit hyperactivity
disorder (ADHD), seizures and speech problems. Further, some people
with NF1 develop cancerous tumors that grow along nerves and are at
a higher risk of developing other forms of cancer. NF1 accounts for
approximately 90% of all neurofibromatosis cases and occurs in
about 1 in 3,000 births. There is no known cure for NF1 and
treatment options vary. Selumetinib (KoselugoTM), a MEK inhibitor
marketed by Alexion Pharmaceuticals, Inc., an AstraZeneca group of
companies, is the only FDA-approved prescription medicine used to
treat children 2 years of age and older with NF1 who have plexiform
neurofibromas that cannot be completely removed by surgery.
About Noonan
syndrome
Noonan syndrome, a genetic disorder, is part of
a group of related conditions, collectively known as RASopathies
that are associated with genes involved in the Ras-Raf-MEK-ERK cell
signaling pathway. Noonan syndrome prevents normal development in
various parts of the body and can affect a person in a wide variety
of ways, including unusual facial characteristics, short stature,
heart defects, growth and muscular skeletal issues, learning
disabilities and possible developmental delays. Noonan syndrome
occurs in approximately 1 in 1,000 to 2,500 people, and
approximately 60% of cases involve gene mutations in the
Ras-Raf-MEK-ERK signaling pathway. There is no known cure for
Noonan syndrome and treatment options vary, including surgery and
growth hormones.
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.
With an experienced team of experts in the fields of neuroscience
and psychopharmacology, Pasithea is developing new molecular
entities for the treatment of psychiatric and neurological
disorders, including Amyotrophic Lateral Sclerosis (ALS) and
Multiple Sclerosis, Neurofibromatosis type 1 and Noonan
syndrome.
Forward Looking Statements
This press release contains statements that
constitute “forward-looking statements.” 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, those set forth in
the Company’s filings with the 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.
Pasithea Therapeutics Corp. Company ContactDr.
Tiago Reis MarquesChief Executive OfficerEmail:
tiago@pasithea.com
Pasithea Therapeutics Corp. Investor
RelationsIn-Site Communications, Inc.Lisa M. WilsonEmail:
lwilson@insitecony.comTel: 212-452-2793
Pasithea Therapeutics Corp. Media ContactsKCSA
Strategic CommunicationsRaquel Cona / Shana MarinoEmail:
pasithea@kcsa.com
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