Dr. Anthony Fauci Confirms ZYESAMI Phase 3 Trial with Remdesivir at Press Briefing by White House COVID-19 Response Team

Rhea-AI Summary

NeuroRx announced the dosing of the first patient in a Phase 3 clinical trial for ZYESAMI (aviptadil acetate) in severely ill COVID-19 patients, part of the ACTIV-3b study led by the NIH. This trial, which includes a randomized, placebo-controlled design, marks a significant step in exploring new COVID-19 therapeutics. The trial will be conducted in multiple countries, and results will be shared with international regulators. NeuroRx is set to merge with Big Rock Partners Acquisition Corp (NASDAQ: BRPA), with an S-4 registration statement filed with the SEC.

Positive

• First patient dosed in Phase 3 clinical trial of ZYESAMI for COVID-19.
• Trial part of the NIH's ACTIV-3b initiative, enhancing credibility.
• NeuroRx recognized as an industry partner in COVID-19 treatment development.
• Intended merger with BRPA could enhance market visibility and funding.

Negative

• None.

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

FAQ

What is the purpose of the Phase 3 clinical trial for ZYESAMI?

The trial aims to evaluate the safety and efficacy of ZYESAMI in treating severely ill COVID-19 patients.

When was the first patient dosed in the ZYESAMI trial?

The first patient was dosed in April 2021 as part of the ACTIV-3b study.

What is the significance of the NIH's involvement in the ZYESAMI trial?

The NIH's involvement enhances the trial's credibility and prioritizes ZYESAMI as a promising COVID-19 therapy.

What are the next steps for NeuroRx after the BRPA merger?

Post-merger, NeuroRx plans to apply for listing on NASDAQ under the symbol 'NRXP' and advance its clinical programs.

What regulatory authorities will receive the results of the ZYESAMI trial?

Results will be shared with international regulatory authorities under ICH-10 accords.