RADNOR, Pa., Feb. 9, 2021 /PRNewswire/ -- 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 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 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 HOLDERS OF 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 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
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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
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statement. You may obtain a free copy of these documents as
described in the preceding paragraph.
MEDIA CONTACT
NeuroRx (United
States):
David
Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
NeuroRx (United
States)
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
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