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EX-99.2 - PRESS RELEASE, DATED MARCH 26, 2021 - NRX Pharmaceuticals, Inc. | brpa_ex992.htm |
EX-99.1 - PRESS RELEASE, DATED MARCH 9, 2021 - NRX Pharmaceuticals, Inc. | brpa_ex991.htm |
8-K - FORM 8-K - NRX Pharmaceuticals, Inc. | brpa_8k.htm |
Exhibit 99.3
NeuroRx Announces
ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its
Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful
Benefit in Survival from Critical COVID-19
RADNOR,
Pa., March 29, 2021 /PRNewswire/ -- NeuroRx, Inc.
today reports 60-day results of the Phase 2b/3 trial of
intravenously-administered ZYESAMI™ (aviptadil acetate) for
the treatment of respiratory failure in critically-ill patients
with COVID-19, which is being developed in collaboration with
Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF). Across all patients and sites,
ZYESAMI™ met the primary endpoint for successful recovery
from respiratory failure at days 28 (P = .014) and 60 (P = .013)
and also demonstrated a meaningful benefit in survival (P = <
.001) after controlling for ventilation status and treatment
site.
In
addition to the robust overall significance across all 196 treated
patients at all 10 clinical sites, the prespecified analysis of
recovery from respiratory failure is clinically and statistically
significant in the 127 patients treated by High Flow Nasal Cannula
(HFNC) (P = .02), compared to those treated with mechanical or
non-invasive ventilation at tertiary care hospitals. In this group,
ZYESAMI™ patients had a 71% chance of successful recovery by
day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of
successful recovery by day 60 vs. 55% in the placebo group (P =
.036). Eighty-four percent (84%) of HFNC patients treated at
tertiary medical centers with ZYESAMI™ survived to day 60
compared with 60% of those treated with placebo (P =
.007).
To the
company's knowledge, ZYESAMI™ is the first COVID-19
therapeutic to demonstrate advantages in both survival and recovery
from critical COVID-19 in a randomized, double-blind multicenter
trial. On the basis of these findings, NeuroRx plans to apply
immediately to the United States Food and Drug Administration
("FDA") for Emergency Use Authorization (EUA) and to subsequently
submit a New Drug Application (NDA).
Recovery
from respiratory failure (without relapse) with discharge from
acute care and survival through the observation period was the
prespecified primary endpoint specified by FDA for the study,
originally intended to be assessed at 28 days and then extended to
60 days based on recently-published FDA guidance. The above
analysis includes all 196 participants who were randomized and
treated in the placebo-controlled, double-blind clinical trial
(www.clinicaltrials.gov NCT04311697)
conducted at 10 US hospitals. Treatment with ZYESAMI™ or
placebo was in addition to standard of care treatment that included
steroids, convalescent plasma, antiviral therapy, anticoagulants,
and various anti-cytokine drugs.
NeuroRx
has announced the commencement of a clinical trial of inhaled
ZYESAMI™ for the treatment of patients with moderate and
severe COVID-19 with the aim of preventing progression to
respiratory failure. NeuroRx has also announced the inclusion of
inhaled ZYESAMI™ in the I-SPY clinical trial platform for
patients with COVID-19 respiratory failure. The company has signed
a clinical trial participation agreement with the National
Institutes of Health.
The
study's coordinating committee, including Professors Dushyantha
Jayaweera, MD, FACP (University of Miami), Richard Lee, MD,
(UC Irvine), and J. Georges Youssef, MD (Houston Methodist
Hospital) commented, "The 60-day
observation framework implemented last month by FDA for critically
ill patients with COVID-19 is more consistent with the clinical
course of this lethal disease than the 28-day time frame originally
adapted from other conditions that cause respiratory distress. The
association of baseline oxygenation status (high flow nasal oxygen
vs. ventilation) is not surprising in that patients who require
mechanical or noninvasive ventilation in order to maintain blood
oxygen are likely to have substantially more damage to the lining
of their lungs compared to patients whose blood oxygen level can be
maintained with high-flow oxygen delivered to the nose. The finding
that patients fared substantially better in tertiary care centers
as compared to regional hospitals may be influenced by the
intensity of the public health crisis at the regional hospitals
that participated in the study, all of which were operating at 200%
or higher overcapacity in their intensive care units with
implementation of temporary ICU beds and shortages of critical care
staff."
Prof. Jonathan
Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, "ZYESAMI has now demonstrated itself in a phase
2/3 trial, conducted under FDA Fast Track Designation, not only to
shorten hospitalization (as was previously reported) but also to
save lives and increase the likelihood of patients returning safely
home to their families. In exactly 12 months, a lifesaving drug has
advanced from concept to clinical success in partnership with
Relief Therapeutics in the midst of a public health emergency that
has claimed the lives of millions. Today's findings confirm
the often dramatic clinical success that has been seen in numerous
patients treated in the US and abroad under emergency use
protocols. We look forward to working with the National
Institutes of Health, the Department of Defense, the FDA, and
regulators around the world to bring this treatment to patients as
quickly as possible."
An
investor conference call will be held today, March
29th at 8:30am
EDT. Participants can dial (+1) 866-373-3402 or join via webcast
at https://bit.ly/3sqPyDS.
Those wishing to ask questions should submit those questions
to ceo@nrxpharma.com.
NeuroRx,
Inc. has signed an agreement to merge with Big Rock Acquisition
Corp. Details may be viewed at http://irdirect.net/filings/viewer/index/1719406/000119312521019278/
About VIP in COVID-19
Vasoactive
Intestinal Polypeptide (VIP) was first discovered by the late
Dr. Sami Said in 1970. Although first identified in the
lung, it was purified from 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 100 peer-reviewed
studies to have potent anti-inflammatory/anti-cytokine activity in
animal models of respiratory distress, acute lung injury, and
inflammation. Most importantly, VIP binds specifically to the
alveolar type II cell (ATII) in the air sac (alveolus) of the
lung. VIP stimulates ATII cells to make the surfactant that
must coat the lining of the lung in order for the lung to exchange
oxygen with the blood. Loss of surfactant causes respiratory
failure and alveolar collapse, which is a hallmark of
COVID-19.
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. Coronavirus infection of the ATII cell shuts
down surfactant production, triggers the formation of inflammatory
cytokines, and causes cell death (cytopathy). VIP is shown to
upregulate surfactant production, block Coronavirus replication in
the ATII cell, block cytokine synthesis, and prevent viral-induced
cell death (cytopathy). To our knowledge, other than
ZYESAMI™, no currently proposed treatments for COVID-19
specifically target this mechanism of action.
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 Aviptadil,
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, MD, MPH, 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".
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. phase 2b/3 clinical trials in
respiratory failure due to COVID-19. Relief also holds a patent
issued in the United States and various other countries
covering potential formulations of RLF-100™. Relief 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.
Cautionary Note Regarding Forward Looking Statements
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.