RADNOR, Pa., April 26, 2021 /PRNewswire/ -- Dosing of the
first patient in a phase 3 clinical trial of ZYESAMI (aviptadil
acetate) was announced by the National Institutes of Health (NIH)
last week. The trial, designated as ACTIV-3b: Therapeutics for
Severely Ill Inpatients With COVID-19
(TESICO) (www.clinicaltrials.gov NCT04843761), will study
ZYESAMI to treat severely ill COVID-19 patients. The study will be
carried out across the United
States as part of the NIH Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) public-private partnership to
prioritize and accelerate development of the most promising
COVID-19 treatments. NeuroRx is designated by NIH as an industry
partner in this initiative, one of the first US small businesses to
be so-designated. Please refer to NIH's news release for more
details.
Dr. Anthony Fauci elaborated on
the need for new COVID-19 therapeutics and discussed this trial in
a White House press briefing on April 23,
2021. He offered the following comment on the inclusion of
ZYESAMI amongst promising COVID-19 therapies, "There's a clinical
trial of therapeutics for severely ill individuals. It's
randomized. It's blinded. Its placebo
controlled. And it's going to study Zyesami – which is a
synthetic version of a vasoactive peptide – and remdesivir alone
and in combination against a placebo." Please refer to the
White House press briefing here. Remdesivir is manufactured by
Gilead Sciences (NasdaqGS:GILD).
The TESICO trial will be conducted in the US, EU, UK, and
additional countries around the world as an FDA-approved phase 3
trial. Results will be shared with international regulatory
authorities under the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals (ICH-10)
accords.
NeuroRx has signed an agreement to merge with Big Rock Partners
Acquisition Corp (Nasdaq:BRPA) and an S-4 is on file with the U.S.
Securities and Exchange Commission.
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".
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.
CORPORATE CONTACT
Jonathan C.
Javitt, M.D., MPH
Chairman & Chief Executive Officer
ceo@nrxpharma.com
MEDIA RELATIONS
Greg Parasmo
gparasmo@nrxpharma.com
(484) 254-6134, ext. 724
INVESTOR RELATIONS
Ryan Sheffield
rsheffield@nrxpharma.com
(484) 254-6134, ext. 723
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SOURCE NeuroRx