Feasibility work underway to determine the
compatibility of NeuroRx’s ZYESAMI™ (aviptadil, synthetic VIP) as a
dry powder formulation using TFF’s Thin-Film Freezing
technology
Dry powder inhalation technology has the
potential to deliver ZYESAMI directly to the lungs
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™ into a dry powder form, which has superior aerosol
properties for delivery directly to the lungs.
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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 Tacrolimus
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.
Cautionary Note Regarding Forward Looking Statements – TFF
Pharmaceuticals:
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.
Cautionary Note Regarding Forward Looking Statements –
NeuroRx:
Statements contained in this press release that are not
historical facts may be forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking
statements generally relate to future events or NeuroRx’s future
financial or operating performance. In some cases, you can identify
forward-looking statements because they contain words such as
"may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or
the negative of these words or other similar terms or expressions
that concern NeuroRx’s expectations, strategy, plans or intentions.
Such forward-looking statements may relate to, among other things,
the outcome of any discussions or applications for the future use
of ZYESAMI, the approvals, timing, and ability to complete the
proposed business combination with BRPA, and the combined company’s
ability to continue listing on Nasdaq after closing the proposed
business combination. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties. NeuroRx does not undertake any
obligation to update forward-looking statements as a result of new
information, future events or developments or otherwise.
Additional Information and Where to Find It
This press release relates to a proposed business combination
and related transactions (the “Transactions”) between NeuroRx and
BRPA. This press release does not constitute an offer to sell or
exchange, or the solicitation of an offer to buy or exchange, any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. BRPA has filed a
registration statement on Form S-4 (“Registration Statement”),
which includes a preliminary proxy statement for the solicitation
of the approval of BRPA’s stockholders, a preliminary prospectus
for the offer and sale of BRPA’s securities in the Transactions and
a preliminary consent solicitation statement of NeuroRx, and other
relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of NeuroRx and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO
READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT
SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE
FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
PROPOSED TRANSACTIONS. Investors and security holders will be able
to obtain free copies of the registration statement, proxy
statement, prospectus and other documents containing important
information about NeuroRx and BRPA once such documents are filed
with the SEC, through the website maintained by the SEC at
http://www.sec.gov. In addition, copies of the documents filed with
the SEC by BRPA can be obtained free of charge on BRPA’s website at
www.bigrockpartners.com or by directing a written request to BRPA
at 2645 N. Federal Highway, Suite 230 Delray Beach, FL 33483.
Participants in the Solicitation
NeuroRx, BRPA and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of BRPA’s stockholders in connection with
the proposed Transactions. Investors and securityholders may obtain
more detailed information regarding the names and interests in the
proposed Transactions of NeuroRx’s and BRPA’s respective directors
and officers in BRPA’s filings with the SEC, including the proxy
statement/consent solicitation statement/prospectus statement. You
may obtain a free copy of these documents as described in the
preceding paragraph.
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version on businesswire.com: https://www.businesswire.com/news/home/20210309005660/en/
NeuroRx 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 Contact: NeuroRx (US): Brian Korb
Solebury Trout bkorb@troutgroup.com 917.653.5122
TFF Pharmaceuticals 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 617-865-0041
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