RADNOR, Pa., Feb. 23, 2021 /PRNewswire/ -- NeuroRx, Inc.
announced today that the Phase 2b/3
trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the
treatment of Respiratory Failure in critically ill patients with
Covid-19 has demonstrated multidimensional benefit around its
prespecified primary endpoint of Recovery from Respiratory Failure
with discharge from hospital and ICU (without relapse) by day 28 in
patients with critical Covid-19 who were treated with High Flow
Nasal Oxygen. Although not envisioned at the start of the clinical
trial, High Flow Nasal Oxygen has become the predominant form of
treatment in Covid-19 respiratory failure, with mechanical
ventilation reserved for those whose blood oxygen levels cannot be
maintained on this less invasive modality. The trial was conducted
at 10 U.S. hospitals under the direction of NeuroRx in
collaboration with RELIEF THERAPEUTICS Holding AG (SIX: RLF; OTCQB:
RLFTF). NeuroRx has signed an agreement to complete a business
combination with Big Rock Partners Acquisition Corporation
(NASDAQ:BRPA).
The clinical trial was originally approved as a 28-day study at
FDA's direction. In December, NeuroRx added a 60-day endpoint based
on the recognition that the traditional 28-day endpoint adopted in
the 1990s for trials in Acute Respiratory Distress Syndrome is not
appropriate for critically ill patients with Covid-19, who are
frequently maintained in the ICU with advanced technologies well
beyond this time point. NeuroRx and other clinical trial sponsors
alerted FDA to this trend and yesterday the FDA published formal
guidance† changing the required time for measuring the
prespecified endpoint of "alive and free of respiratory failure" in
critically ill patients to 60 days. Interim data are being
reported because they were unblinded as per the original protocol
and the last patient in the trial reached day 60 yesterday.
Therefore, study conduct cannot be adversely influenced by release
of these interim findings.
At 28 days, patients treated with ZYESAMI™ demonstrate 35%
higher likelihood of recovery from respiratory failure with
continued survival compared to patients treated with placebo
(Hazard Ratio 1.53; P=.08). In tertiary care hospitals,
ZYESAMI-treated patients were 46% more likely to recover and return
home before day 28 (Hazard Ratio controlling for age and severity
1.84; P=.058). Should these trends continue through day 60, they
have the potential to reach statistical significance. At day 28, a
highly significant 10-day difference in median time to
recovery and hospital discharge has emerged in ZYESAMI-treated
patients compared to those treated with placebo (P<.006).
Should the above trends continue through day 60, NeuroRx
anticipates filing a request for Emergency Use Authorization in
this population of critically ill patients (i.e. those on High Flow
Nasal Oxygen) who have exhausted all currently approved treatments.
FDA decisions implement a benefit/risk framework. NeuroRx
previously announced the high degree of safety observed with use of
ZYESAMI. This safety has continued to be documented in the
more than 300 additional patients treated under the Expanded Access
Protocol and in patients who have filed requests under the federal
Right to Try act.
Yesterday's guidance emphasizes the importance of analyzing
patient outcomes by treatment subgroup and, in this case, the study
did not recruit enough patients treated with mechanical ventilation
to confirm the benefit seen in open-label studies. In the seven
months that have elapsed since the trial began, mechanical
ventilation has gone from first-line therapy to treatment of last
resort for patients with Covid-19. Recognizing this, NeuroRx signed
clinical trial agreements with the I-SPY clinical trial platform
and the National Institutes of Health under which ZYESAMI will
continue to be evaluated in patients who require mechanical
ventilation.
The study's principal investigators, Dushyantha Jayaweera, M.D.,
FACP (University of Miami), Professors
J. Georges Youssef, M.D. (Houston
Methodist Hospital), and Richard
Lee, M.D. (University of California,
Irvine), commented, "We are excited to report that
ZYESAMI demonstrates a highly significant reduction in time to
recovery compared to patients treated with placebo in those treated
with High Flow Nasal Oxygen, together with increased likelihood of
recovery and excellent safety. We look forward to learning whether
this benefit can also be shown for patients treated with other
stages of Covid-19 with inhaled forms of ZYESAMI. We look
forward to working with the sponsor to secure emergency use
authorization for ZYESAMI in this population of
patients."
Jonathan C. Javitt, M.D., M.P.H.,
CEO of NeuroRx, added, "We look forward to reporting the final
60-day efficacy data shortly. We are indebted to the researchers,
patients, and families who have helped us demonstrate this
meaningful clinical benefit for ZYESAMI. We are honored to name the
drug in honor of the late Prof. Sami
Said, who discovered its active ingredient, VIP.
Additional efficacy data on patients who require mechanical
ventilation will be obtained from ongoing research supported by
BARDA and the National Institutes of Health, in addition to our
newly initiated study of inhaled use ZYESAMI in hospitalized
patients who have not yet developed respiratory failure."
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 RELIEF THERAPEUTICS Holding AG
Relief
focuses primarily on clinical-stage programs based on molecules of
natural origin (peptides and proteins) with a history of clinical
testing and use in human patients or a strong scientific rationale.
Currently, Relief is concentrating its efforts on developing new
treatments for respiratory disease indications. Its lead drug
candidate RLF-100™ (aviptadil) is being investigated
in two placebo-controlled U.S. late-stage clinical trials in
respiratory deficiency due to COVID-19. Relief holds a patent
issued in the United States and
various other countries covering potential formulations of
RLF-100™.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss
Exchange under the symbol RLF and quoted in the U.S. on OTCQB under
the symbol RLFTF. www.relieftherapeutics.com Follow us on
LinkedIn.
CORPORATE
CONTACTS
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INVESTOR
RELATIONS
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NeuroRx,
Inc.
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NeuroRx (United
States)
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Jonathan C. Javitt,
M.D., MPH
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Brian Korb
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Chairman and Chief
Executive Officer
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Solebury
Trout
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ceo@neurorxpharma.com
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bkorb@troutgroup.com
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917-653-5122
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MEDIA
CONTACT
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NeuroRx (United
States):
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David
Schull
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Russo Partners,
LLC
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david.schull@russopartnersllc.com
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858-717-2310
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Disclaimer - Relief:
This communication expressly or implicitly contains certain
forward-looking statements concerning RELIEF THERAPEUTICS Holding
AG. The results reported herein may or may not be indicative of the
results of future and larger clinical trials for the treatment of
respiratory failure from COVID-19 or other respiratory diseases.
Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual
results, financial condition, performance or achievements of RELIEF
THERAPEUTICS Holding AG to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties, including whether the results
described herein will be sufficient to gain any regulatory
approvals for RLF-100™. RELIEF THERAPEUTICS Holding AG is providing
this communication as of this date and do not undertake to update
any forward-looking statements contained herein as a result of new
information, future events or otherwise.
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.
*(www.clinicaltrials.gov NCT04311697)
† COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention.
https://www.fda.gov/media/137926/download
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