Full Press Release Details
NeuroRX and TFF Pharmaceuticals
Announce Entering Into Feasibility
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
Dry powder inhalation technology has the potential to deliver
ZYESAMI directly to the lungs
RADNOR, Pa. & AUSTIN, Texas, March 9,
WIRE)--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.
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
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
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
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
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
TFF Pharmaceuticals' Thin Film Freezing (TFF) platform was
designed to improve the solubility and absorption of poorly