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8-K - CURRENT REPORT - NRX Pharmaceuticals, Inc. | brpa_8k.htm |
Exhibit 99.1
NeuroRx
reports Initial Phase 2b/3 Study Results Demonstrating Significant
Benefit of ZYESAMI™ (aviptadil) in
Reducing
Hospital Stay among Patients with Respiratory Failure due to
Critical COVID-19
If Authorized for Use, ZYESAMI™ Would be First Treatment
Specifically for Critically Ill Patients with Respiratory
Failure
RADNOR, Pa. Feb. 9, 2021 0730– NeuroRx, Inc. today
reported preliminary results from their Phase 2b/3 trial of
ZYESAMI™ (aviptadil, previously RLF-100) performed in
collaboration with Relief Therapeutics Holdings, AG (SIX:RLF;
OTCQB:RLFTF) in patients with respiratory failure due to Critical
COVID-19. The study showed that patients who were treated
with the maximal standard of care plus ZYESAMI were discharged
sooner from the hospital compared to those treated with placebo
plus maximal standard of care (SOC). If authorized for use, ZYESAMI
would be the first drug indicated specifically for COVID-19
patients who are critically ill with respiratory
failure.
Jonathan
Javitt, M.D., M.P.H., CEO of NeuroRx, said: “We are greatly
encouraged by these preliminary findings and believe they are
indicative of a biologic effect of aviptadil in hastening recovery
from Critical COVID-19. We expect to discuss with the Food and Drug
Administration and other regulatory authorities the submission of
an Emergency Use Authorization (EUA) so that ZYESAMI can be
available for treating this population that is at immediate risk of
death and for which there is no approved
therapy.”
With
the improvement in survival since the start of the pandemic,
differences in patient survival were not seen at day 28, and
patients are now being followed through day 60. The study has not
identified an overall difference in the stated primary endpoint of
recovery from respiratory failure from summary data. However,
investigators are in the process of confirming the timing of each
case of recovery from medical records, following which the
study’s investigators’ committee will review each case
prior to patient-level unblinding of this endpoint. Those data are
expected within a few weeks and will provide further insight into
the benefits of ZYESAMI. A blinded substudy of radiographic
improvement is similarly underway.
Among
the secondary efficacy endpoints evaluated in patients treated with
High Flow Nasal Cannula (HFNC) therapy and with Mechanical
Ventilation, ZYESAMI showed an advantage in 15 of 16 comparisons
and demonstrated a 40% or better advantage (hazard ratio <0.7).
The likelihood of this magnitude of advantage being seen by chance
alone is about 1 in 2,000 (P=.0005). This difference includes at
least a five-day median reduction in hospital stay. (P=.043). The
largest difference observed was among those treated with HFNC who
experienced a median of 11 fewer days in hospital (15 vs.
26).
Dr.
Javitt said: “The data provide preliminary support for
ZYESAMI as a drug that may help get critically-ill patients home to
their families sooner. The hospitalization data further suggest
that patients treated at an earlier stage of illness (i.e., those
who can be managed with HFNC) may have a better response to
treatment. We have launched a phase 2/3 trial to explore
ZYESAMI’s inhaled use in patients who are not yet in
respiratory failure.
“Further
study of ZYESAMI’s role in critical COVID-19 will be
conducted under the BARDA and DOD Medical Countermeasures-funded
I-SPY trial.
Dr.
Javitt added: “To our knowledge this is the first
demonstration of clinically and statistically-significant benefit
by any therapeutic agent in patients with COVID-19 respiratory
failure in a randomized, double blind, prospective trial. Other
COVID-19 therapeutics have demonstrated clinical advantage in
patients with non-critical COVID-19 (ordinal scale 4 and 5) but
have not demonstrated benefit in those with Critical COVID-19
(ordinal scale 6 and 7). Steroids have demonstrated benefit in open
label studies. However, no randomized controlled trial to
date has shown efficacy when patients are in respiratory failure
and require High Flow Nasal Cannula, Non-invasive ventilation, or
Mechanical Ventilation to maintain blood oxygenation. ZYESAMI, if
authorized, would be the first drug for such critically ill
patients. Of note, the patients who received either drug or placebo
in this trial also received all approved and standard of care
treatments including Remdesivir, anti-cytokine drugs, steroids, and
anticoagulants.”
Dr.
Javitt added: “We are forever indebted to the study
coordinators, nurses, respiratory therapists, and doctors who
carried out this study in the midst of a public health calamity
that so far has claimed the lives of nearly half a million
Americans and millions worldwide. Our study teams kept the effort
going despite contracting COVID themselves, losing family members,
and dealing with an unimaginable daily reality.
The
data were generated in multicenter clinical trial whose subjects
were COVID-19 patients with respiratory failure being treated with
the maximal standard of care that included anti-coagulants,
steroids, convalescent plasma and antiviral drugs. The
primary endpoint was the resolution of respiratory failure within
28 days after treatment started. The secondary endpoints were
patient survival, time to ICU discharge, time to hospital
discharge, time to return to NIAID score of 6-8, and
safety.
A total
of 203 patients were screened and consented to participate in the
study; 136 were given ZYESAMI. while 67 received the standard of
care. All patients were evaluated through Day 28 with planned
long-term follow-up through day 60. A total of 138 patients (91
ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65
ZYESAMI, 31 SOC) were discharged from the hospital by Day 28. Data
analysis per protocol is ongoing.
The
study, conducted in 10 medical centers, also showed the safety of
the drug when administered by intravenous infusion in the ICU. No
unexpected side effects identified. The most common side effects of ZYESAMI in the
clinical trial were mild to moderate diarrhea (seen in 30% of
ZYESAMI-treated vs. 1.5% of placebo-treated patients) and systemic
hypotension (low blood pressure) seen in 31 ZYESAMI-treated
patients vs. 25 placebo patients. There were two deaths in the
study related to hypotension, both of which occurred more than a
week after treatment. One patient was in the ZYESAMI group, and the
other was in the placebo group. All potentially serious adverse
effects were investigated by a board-certified critical care
physician together with site investigators, and none was deemed
drug-related.
Conference Call Information
NeuroRx
will host a conference call and webcast on February 9, 2021 at 9:00
a.m. EST to discuss study results. To participate in the conference
call, dial +1 866-373-3402 (Toll-Free) or +1 201-689-7825
(International), shortly before 9:00 a.m. EST. The webcast can also
be accessed directly at https://78449.themediaframe.com/dataconf/productusers/nrx/mediaframe/43588/indexl.html.
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 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, 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 to
transmission of oxygen to the body.
COVID-19-related
respiratory failure is caused by selective infection of the ATII
cell by the SARS-CoV-2 virus. They 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.
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. The Company 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.
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 the Company's future financial or
operatingperformance. 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 the Company’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. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties. The Company 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
document relates to a proposed Business Combination and related
transactions (the “Transactions”) between the Company
and Big Rock Partners Acquisition Corp. (“BRPA”). 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. 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 transaction and a
preliminary consent solicitation statement of the Company, and
other relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of the Company and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERSOF THE COMPANY 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 BECAUSETHEY 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 the Company 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
The
Company, 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 the Company’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.