Pasithea
Therapeutics Acquires AlloMek Therapeutics
-- Expands CNS
Product Portfolio with Addition of CIP-137401, a Macrocyclic,
Next-Generation MEK Inhibitor
-- Plans to File
IND Application with the FDA to Enter the Clinic in 2H
2023
-- Plans to
Initiate a Phase 1 Clinical Trial in the U.S. for Neurofibromatosis
Type 1 (NF1)
-- Management to
Host an Investor Webcast Today at 9 a.m. ET
Miami Beach,
FL / October 12, 2022 --
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, while
also positioning us for long-term growth opportunities with
potential synergy with our existing tolerizing program that 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 Connecticut Innovation Fund
(CI), a venture capital firm as a long term focused institutional
stockholder who has supported the development of CIP-137401 to our
stockholder registry."
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 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 also 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
kinase 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, 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.
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 Contact
Dr. Tiago Reis Marques
Chief Executive Officer
Email:
tiago@pasithea.com
Pasithea
Therapeutics Corp. Investor Relations
In-Site Communications,
Inc.
Lisa M. Wilson
Email:
lwilson@insitecony.com
Tel: 212-452-2793
Pasithea
Therapeutics Corp. Media Contacts
KCSA Strategic
Communications
Raquel Cona / Shana
Marino
Email:
pasithea@kcsa.com