EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Miscellaneous
Relief, NeuroRx and Quantum Leap announce the inclusion of ZYESAMI(TM)
(RLF-100(TM): aviptadil) in the I-SPY COVID-19 Trial
2021-01-11 / 07:00
*Relief, NeuroRx and Quantum Leap announce the inclusion of ZYESAMI(TM)
(RLF-100(TM): aviptadil) in the I-SPY COVID-19 Trial*
*Geneva, Switzerland and Radnor, Pa, USA, January 11, 2021 -* RELIEF
THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("*Relief*" or the
"*Company*"), NeuroRx, Inc. 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(TM)
(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(TM) will be included as one
of the first drugs targeting Respiratory Failure in critically ill COVID-19
patients.
The inclusion of ZYESAMI(TM) 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(TM) 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(TM) (PREVIOUSLY RLF-100(TM): AVIPTADIL)*
*ZYESAMI(TM) (RLF-100(TM): 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(TM) 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(TM) between the two FDA-cleared protocols (randomized and
expanded access). Information on the RLF-100(TM) Expanded Access Program can
be found at https://www.neurorxpharma.com/our-services/rlf-100 [1].
*ABOUT RELIEF*
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-100TM
(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-100TM.
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 [2]
Follow us on *LinkedIn [3].*
*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(TM), which has
been awarded FDA Fast Track designation (previously RLF-100(TM): 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 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
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January 11, 2021 01:00 ET (06:00 GMT)