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8-K - CURRENT REPORT - NRX Pharmaceuticals, Inc. | brpa_8k.htm |
Exhibit 99.1
NeuroRx, Relief, and Quantum Leap announce the inclusion of
ZYESAMI™ (RLF-100™: aviptadil) in the I-SPY COVID-19
Trial
RADNOR, Pa. and GENEVA, Jan. 11,
2021 /PRNewswire/ — NeuroRx, Inc. and RELIEF
THERAPEUTICS Holding AG
(SIX: RLF,OTCQB: RLFTF)
(“Relief”), and the Quantum Leap Healthcare
Collaborative (“Quantum Leap”) of San
Francisco announce that NeuroRx and QLHC have signed a
Clinical Trial Participation Agreement for the inclusion of
ZYESAMI™ (RLF-100TM:
aviptadil) in the I-SPY COVID-19 Clinical Trial. Quantum Leap
is the sponsor of the I-SPY COVID-19 Trial, a platform trial
that is assessing multiple drugs for the treatment of patients with
Critical COVID-19 who are hospitalized or in intensive
care units. ZYESAMI™ will be included as one of the
first drugs targeting Respiratory Failure in critically ill
COVID-19 patients.
The inclusion of ZYESAMI™ in the I-SPY
COVID-19 Trial follows a request from the U.S. Department
of Health and Human Services and the Department of Defense for
investigational drugs capable of targeting the most acutely ill
patients with COVID-19. ZYESAMI™ has been granted
Fast Track designation by the U.S. Food & Drug Administration
(FDA) for the treatment of Critical COVID-19 in
patients with Respiratory Failure.
In December 2020, Dr. Robert Kadlec, HHS Assistant
Secretary for Preparedness and Response, issued a public statement
that “Through our Operation Warp Speed partnership, we have
worked feverishly with private industry to develop and make
treatments available to reduce hospitalization, either shortening
the length of stay or treating people with mild or moderate
COVID-19 infections before they have to be hospitalized. While
we’re making significant progress, treatments to save lives
of the sickest patients, such as patients in intensive care or on
ventilators, remain an urgent need.”
I-SPY is a platform clinical trial that uses a similar protocol as
a traditional clinical trial, but that compares multiple
investigational agents combined with a “backbone” of
the standard of care. The trial is designed to rapidly
identify those agents that have a large impact on reducing disease
severity, including reduced mortality, reducing or avoiding time on
ventilation and other longer-term comorbidities. Patients receive
one of several products being studied and the results then are
compared to the current standard of care.
“We are excited to be collaborating with NeuroRx, an
innovative company developing agents that have the potential to
significantly impact the time to recovery and mortality in these
severely ill COVID-19 patients,” states Dr. Laura
Esserman, one of the lead investigators of the I-SPY COVID-19
Trial. “Our adaptive platform trial setting is the ideal type
of study to follow a trial that has findings suggesting agent
effectiveness. We have the ability to independently verify impact,
as well as test different modes of delivery in a pandemic
timeframe.”
“We at NeuroRx, together with our partners at Relief, are
honored to have been selected by Quantum Leap for inclusion in the
I-SPY trials platform. This will enable us to gather data on the
use of inhaled aviptadil in the treatment of Critical COVID-19, as
a complement to data on the use of intravenous aviptadil in the
phase 2b/3 trial we are just concluding. We also hope to
demonstrate in a second phase 2b/3 trial that aviptadil can be
given in a more convenient mode of administration and show benefit
in patients who are able to self-administer inhaled
medications,” said Jonathan C. Javitt, MD, MPH, CEO and
Chairman of NeuroRx.
About ZYESAMI™ (RLF-100™: aviptadil)
ZYESAMI™ (RLF-100™: aviptadil) is a formulation of
Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami
Said’s original work at Stony Brook University, for
which Stony Brook was awarded an FDA Orphan Drug Designation in
2001. VIP is known to be highly concentrated in the lungs, where it
inhibits coronavirus replication, blocks the formation of
inflammatory cytokines, prevents cell death, and upregulates the
production of surfactant. FDA has granted IND authorization for
intravenous and inhaled delivery of aviptadil for the treatment of
COVID-19 and awarded Fast Track designation.
ZYESAMI™ is being investigated in two
placebo-controlled US phase 2b/3 clinical trials in
respiratory deficiency due to COVID-19. Since July 2020, more
than 300 patients with Critical COVID-19 and Respiratory Failure
have been treated with RLF-100™ between the two FDA-cleared
protocols (randomized and expanded access). Information on the
RLF-100™ Expanded Access Program can be found
at https://www.neurorxpharma.com/our-services/rlf-100.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug
development experience and by former senior executives of
AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to
its work on ZYESAMI™, which has been awarded FDA Fast Track
designation (previously RLF-100™: 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. The Company has recently announced a plan to merge
with Big Rock Partners Acquisition Corp (NASDAQ:BRPA)
(“Big Rock”), following which it is expected to trade
on the NASDAQ as 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 deficiency 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 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
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501(c)(3) charitable
organization established in 2005 as a collaboration between medical
researchers at University of California, San Francisco, academic
medical sites and clinical researchers (nationwide), the
pharma industry and healthcare technology leaders. Its mission is
to integrate high-impact research with clinical processes and
systems technology, resulting in improved data management and
information systems, greater access to clinical trial matching and
sponsorship, and greater benefit to providers, patients and
researchers. Its goal is to improve and save lives. Quantum Leap
provides sponsorship as well as operational, financial, and
regulatory oversight to the I-SPY Trials. For more information,
visit www.QuantumLeapHealth.org.
About Big Rock Partners Acquisition Corp.
Big Rock Partners Acquisition Corp. is a blank check company formed
for the purpose of entering into a merger, stock exchange, asset
acquisition, stock purchase, recapitalization, reorganization, or
other similar business combination with one or more businesses or
entities. Big Rock’s management team includes Richard
Ackerman, Chairman, President, and Chief Executive Officer,
and Bennett Kim, Chief Financial Officer, Chief Investment
Officer, Corporate Secretary and Director. Big Rock’s common
stock, units, rights and warrants are quoted on the Nasdaq Capital
Market under the ticker symbols BRPA, BRPAU, BRPAR and BRPAW,
respectively.
Additional Information and Where to Find It
This document relates to a proposed transaction between NeuroRx and
Big Rock. This document 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. Big Rock intends to file
a registration statement on Form S-4 (“Registration
Statement”), which will include a proxy statement for the
solicitation of Big Rock shareholder approval, a prospectus for the
offer and sale of Big Rock securities in the transaction and a
consent solicitation statement of NeuroRx, and other relevant
documents with the Securities and Exchange Commission
(“SEC”). The proxy statement/consent solicitation
statement/prospectus will be mailed to stockholders of Big Rock and
NeuroRx as of a record date to be established for voting on the
proposed business combination. INVESTORS AND SECURITY HOLDERS OF
BIG ROCK AND NEURORX ARE URGED TO READ THE REGISTRATION STATEMENT,
PROXY STATEMENT/CONSENT SOLICITATION STATEMENT/PROSPECTUS 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 TRANSACTION. 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 Big Rock and
NeuroRx once such documents are filed with the SEC, through the
website maintained by the SEC at http://www.sec.gov.
Additional Information Posted to Website
Big Rock will post information regarding the proposed transaction
promptly at www.bigrockpartners.com.
An investor presentation has been furnished by Big Rock to the SEC
on a current report on Form 8-K, which can be viewed at the
SEC’s website at www.sec.gov and www.bigrockpartners.com.
Big Rock intends to use its website as additional means of
disclosing information to investors, the media, and others
interested in Big Rock. It is possible that certain information
that Big Rock posts to its website could be deemed material
information, and Big Rock encourages investors, the media, and
others interested in Big Rock to review the business and financial
information that Big Rock posts on its website as such information
could be deemed to be material information.
Participants in the Solicitation
Big Rock, NeuroRx and EarlyBirdCapital and their respective
directors and executive officers, under SEC rules, may be deemed to
be participants in the solicitation of proxies of Big Rock’s
shareholders in connection with the proposed transaction. Investors
and securityholders may obtain more detailed information regarding
the names and interests in the proposed transaction of Big
Rock’s directors and officers in Big Rock’s filings
with the SEC, including the forthcoming proxy statement/consent
solicitation statement/prospectus statement. You may obtain a free
copy of these documents as described in the preceding
paragraph.
No Offer or Solicitation
This communication shall neither constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which the offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such
jurisdiction.
Cautionary Note Regarding Forward Looking Statements
Neither Big Rock, NeuroRx nor any of their respective affiliates
makes any representation or warranty as to the accuracy or
completeness of the information contained in this press release.
This press release is not intended to be all-inclusive or to
contain all the information that a person may desire in considering
the proposed transaction discussed herein. It is not intended to
form the basis of any investment decision or any other decision in
respect of the proposed transaction.
This press release includes “forward-looking
statements” within the meaning of the federal securities laws
with respect to the proposed transaction between NeuroRx, Inc. and
Big Rock, including statements regarding the benefits of the
transaction, the anticipated timing of the transaction, the drugs
under development by NeuroRx and the markets in which it operates.
Big Rock’s and NeuroRx’s actual results may differ from
its expectations, estimates and projections and consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements generally are
identified by the words “aspire,” “expect,”
“estimate,” “project,”
“budget,” “forecast,”
“anticipate,” “intend,” “plan,”
“may,” “will,” “will be,”
“will continue,” “will likely result,”
“could,” “should,”
“believe(s),” “predicts,”
“potential,” “continue,”
“future,” “opportunity,”
“strategy,” and similar expressions are intended to
identify such forward-looking statements. These forward-looking
statements include, without limitation, Big Rock’s and
NeuroRx’s expectations with respect to future performance and
anticipated financial impacts of the proposed
transaction.
These forward-looking statements involve significant risks and
uncertainties that could cause the actual results to differ
materially from the expected results. Most of these factors are
outside Big Rock’s and NeuroRx’s control and are
difficult to predict. Factors that may cause such differences
include, but are not limited to: (1) the approvals, timing, and
ability to complete the proposed business combination, which may
adversely affect the trading price of Big Rock’s securities;
(2) Big Rock’s ability to remain listed on the Nasdaq Capital
Market prior to the closing of the proposed business combination;
(3) the combined company’s continued listing on the NASDAQ
Capital Market after closing of the proposed business combination;
(4) the benefits of the proposed business combination, including
future financial and operating results of the combined company; (5)
the inherent uncertainty associated with the FDA approval process;
(6) the risk that the proposed transaction disrupts current plans
and operations of NeuroRx as a result of the announcement and
consummation of the transaction described therein and herein; (7)
costs related to the proposed business combination; (8) changes in
applicable laws or regulations; (9) the possibility that the
combined company may be adversely affected by other economic,
business, and/or competitive factors; (10) the impact of COVID-19
or other adverse public health developments; and (11) other risks
and uncertainties that will be detailed in the proxy
statement/consent solicitation statement/prospectus and
registration statement to be filed on Form S-4 with the SEC and as
indicated from time to time in Big Rock’s filings with the
SEC. These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking
statements.
Big Rock and NeuroRx caution that the foregoing list of factors is
not exclusive. Big Rock and NeuroRx caution readers not to place
undue reliance upon any forward-looking statements, which speak
only as of the date made. Neither Big Rock nor NeuroRx undertake or
accept any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements to reflect
any change in its expectations or any change in events, conditions
or circumstances on which any such statement is based.
Disclaimer: This communication
expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their
businesses. The results reported herein may or may not be
indicative of the results of future and larger clinical trials for
RLF-100™ for the treatment of COVID-19. 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
and/or NeuroRx, Inc. to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. RELIEF THERAPEUTICS Holding AG is
providing this communication as of this date and does not undertake
to update any forward-looking statements contained herein as a
result of new information, future events or
otherwise.
CORPORATE CONTACTS
|
INVESTOR RELATIONS
|
|
|
NeuroRx, Inc.
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NeuroRx (United States)
|
Jonathan
C. Javitt, M.D., MPH
|
Brian
Korb
|
Chairman
and Chief Executive Officer
|
Solebury
Trout
|
ceo@neurorxpharma.com
|
bkorb@troutgroup.com
|
|
917-653-5122
|
RELIEF THERAPEUTICS Holding AG
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|
Raghuram
(Ram) Selvaraju, Ph.D., MBA
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Relief (Europe):
|
Chairman
of the Board
|
Anne
Hennecke / Brittney Sojeva
|
contact@relieftherapeutics.com
|
MC
Services AG
|
|
relief@mc-services.eu
|
|
+49
(0) 211-529-252-14
|
MEDIA CONTACT
|
|
|
|
NeuroRx (United States):
|
|
David
Schull
|
|
Russo
Partners, LLC
|
|
david.schull@russopartnersllc.com
|
|
858-717-2310
|
|
|
|
Relief (Europe):
|
|
Anne
Hennecke / Brittney Sojeva
|
|
MC
Services AG
|
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relief@mc-services.eu
|
|
+49
(0) 211-529-252-14
|
|
SOURCE NeuroRx
CORPORATE CONTACTS
NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
ceo@neurorxpharma.com
Relief Therapeutics Holdings SA
Raghuram (Ram) Selvaraju, Ph.D., MBA
Chairman of the Board
contact@relieftherapeutics.com
MEDIA CONTACT
NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14
INVESTOR RELATIONS
NeuroRx (United States)
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122