RADNOR, Pa. and
AUSTIN, Texas, March 9, 2021
/PRNewswire/ -- NeuroRx, Inc. and TFF Pharmaceuticals, Inc.
(NASDAQ: TFFP) are announcing that the companies have entered
into a feasibility and material transfer agreement (Feasibility
Agreement). Under the Feasibility Agreement, NeuroRx is
delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to
TFF in order to perform feasibility formulation work and testing.
The goal of this feasibility work is to formulate and identify an
optimal, long term-stable formulation of ZYESAMI™ in a dry powder
form which has superior aerosol properties for delivery directly to
the lungs.
ZYESAMI is a synthetic form of a naturally occurring peptide
found in the lung called Vasoactive Intestinal Peptide (VIP), which
is known to protect the Alveolar Type II cell that is targeted by
the SARS-CoV-2 virus. The symptoms of COVID-19 are
attributable to decreased surfactant production and increased
cytokine production caused by Coronavirus infection of the Type II
cell. This may also be a common pathway in sepsis-induced
Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor
induced pneumonitis associated with certain cancer drugs.
Loss of surfactant production in the lung may be the direct
cause of the profound hypoxia or respiratory failure seen in
COVID-19. The ability to deliver VIP directly to the lung
via inhalation could have important therapeutic implications and
potentially broaden the application of the drug to patients less
severely affected with Covid-19.
"We are excited that ZYESAMI has demonstrated a highly
significant reduction in time to hospital discharge for seriously
ill Covid-19 patients treated with High Flow Nasal Oxygen, along
with an increased likelihood of recovery and excellent safety,"
said Jonathan C. Javitt, M.D.,
M.P.H., CEO of NeuroRx. "Although our current production methods
yield a drug that is sufficiently stable for emergency use, a
long-term, shelf stable formulation will be needed for ongoing use
of ZYESAMI, once the pandemic subsides. The thin film freezing
technology holds great promise in potentially making this available
to patients with other stages of Covid-19 with an inhaled form of
ZYESAMI."
"The work being done by the NeuroRx team with ZYESAMI on
behalf of critically ill patients with Covid-19 Respiratory Failure
is both remarkable and gratifying," said Glenn Mattes, President & CEO of TFF
Pharmaceuticals, "The potential opportunity to bring this important
new therapeutic to patients earlier in the treatment cycle is
exciting. We are very pleased to be collaborating with the NeuroRx
Team with our thin-film freezing technology."
About VIP in COVID-19
Vasoactive Intestinal
Polypeptide (VIP) was first discovered by the late Dr. Sami
Said in 1970, for whom ZYESAMI™ is named. Although first
identified in the intestinal tract, VIP is now known to be produced
throughout the body and to be primarily concentrated in the lungs.
VIP has been shown in more than 500 peer-reviewed studies to have
potent anti-inflammatory/anti-cytokine activity in animal models of
respiratory distress, acute lung injury, and inflammation. Most
importantly, 70% of the VIP in the body is bound to a rare cell in
the lung, the alveolar type II cell (ATII), that is critical in the
production of lung surfactant that is essential to transmission of
oxygen from the air to the blood by the pulmonary epithelial cells
that line the air sacs (alveoli) of the lung. Initial radiographic
changes in Covid-19 are suggestive of collapse of these
alveoli.
Covid-19-related respiratory failure is caused by selective
infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells
are vulnerable because of their (ACE2) surface receptors, which
serve as the route of entry for the virus. These specialized cells
manufacture surfactant that coats the lung and is essential for
oxygen exchange. Loss of surfactant causes collapse of the air sacs
(alveolae) in the lung and results in respiratory failure.
VIP is shown to block Coronavirus replication in the ATII cell,
block cytokine synthesis, block viral-induced cell death
(cytopathy), and upregulate surfactant production. To our
knowledge, other than ZYESAMI™, no currently proposed treatments
for Covid-19 specifically target these vulnerable Type II cells.
Recent laboratory findings suggest that VIP directly interferes
with the spike protein complex of the SARS-CoV-2 virus.
About NeuroRx, Inc.
NeuroRx draws upon
more than 100 years of collective drug development experience from
senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and
PPD. In addition to its work on ZYESAMI™, NeuroRx has been awarded
Breakthrough Therapy Designation and a Special Protocol Agreement
to develop NRX-101 in suicidal bipolar depression and is currently
in Phase 3 trials. Its executive team is led by Prof. Jonathan
C. Javitt, M.D., M.P.H., who has served as a health advisor to four
Presidential administrations and worked on paradigm-changing drug
development projects for Merck, Allergan, Pharmacia, Pfizer,
Novartis and MannKind, together with Robert Besthof, MIM, who
served as the Global Vice President (Commercial) for Pfizer's
Neuroscience and Pain Division. NeuroRx recently announced a
plan to complete a business combination with Big Rock Partners
Acquisition Corp (NASDAQ: BRPA) ("BRPA") and intends to apply for
listing on the NASDAQ under the proposed symbol "NRXP". For more
information, visit www.neurorxpharma.com.
About TFF Pharmaceuticals' Thin Film Freezing technology
platform
TFF Pharmaceuticals' Thin Film Freezing (TFF)
platform was designed to improve the solubility and absorption of
poorly water-soluble drugs and is particularly suited to generate
dry powder particles with properties targeted for inhalation
delivery, especially to the deep lung, an area of extreme interest
in respiratory medicine. The TFF process results in a "Brittle
Matrix Particle," which possesses low bulk density, high surface
area, and typically an amorphous morphology, allowing the particles
to supersaturate when contacting the target site, such as lung
tissue. Based upon laboratory experiments the aerodynamic
properties of the particles are such that the portion of a drug
deposited to the deep lung has the potential to reach as high as 75
percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals,
Inc. is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative drug products based on
its patented Thin Film Freezing, or TFF, technology platform. Early
testing confirms that the TFF platform can significantly improve
the solubility and absorption of poorly water-soluble drugs, a
class of drugs that comprises approximately one-third of the major
pharmaceuticals worldwide, thereby improving their
pharmacokinetics. TFF Pharmaceuticals has two lead drug
candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation
Powder. The Company plans to add to this pipeline by collaborating
with large pharmaceutical partners. The TFF Platform is protected
by 42 patents issued or pending in the US and internationally. To
learn more about TFF Pharmaceuticals and its product
candidates, visit the Company's website
at https://tffpharma.com.
Safe Harbor
This press release contains forward-looking statements
regarding TFF Pharmaceuticals, Inc., including the benefits of
the Company's TFF platform and a potential its dry powder version
of NeuroRx's ZYESAMI. Those forward-looking statements involve
known and unknown risks, uncertainties and other factors that could
cause actual results to differ materially. Among those factors are:
(i) the risk that NeuroRx and the Company may not be able to
produce a dry powder version NeuroRx's ZYESAMI, (ii) the risk that
NeuroRx and the Company may not be able to successfully conclude
clinical testing or obtain pre-market approval of a dry powder
version of NeuroRx's ZYESAM, (iii) no drug product incorporating
the TFF platform has received FDA pre-market approval or otherwise
been incorporated into a commercial drug product, and (iv) those
other risks disclosed in the section "Risk Factors" included in the
Company's prospectus supplement filed with
the SEC on December 8, 2020. TFF
Pharmaceuticals cautions readers not to place undue reliance
on any forward-looking statements. TFF
Pharmaceuticals does not undertake, and specifically
disclaims, any obligation to update or revise such statements to
reflect new circumstances or unanticipated events as they occur,
except as required by law.
Corporate Contacts
NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
ceo@neurorxpharma.com
Media Contact:
NeuroRx (US):
David Schull
Russo Partners, LLC
David.schull@russopartnersllc.com
858.717.2310
Investor Relations:
NeuroRx (US):
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917.653.5122
TFF Contacts:
Glenn
Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973
Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358
Investor Relations and
Media Contact:
Paul
Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779
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SOURCE NeuroRx; TFF Pharmaceuticals