Full Press Release Details
NeuroRx, Relief, and Quantum Leap announce the inclusion of
ZYESAMI (RLF-100 : aviptadil) in the I-SPY COVID-19
RADNOR, Pa. and GENEVA, Jan. 11,
2021 /PRNewswire/ NeuroRx, Inc. and RELIEF
THERAPEUTICS Holding AG
(SIX: RLF,OTCQB: RLFTF)
( Relief ), 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
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 will be included as one of the
first drugs targeting Respiratory Failure in critically ill
The inclusion of ZYESAMI 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 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
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 (RLF-100 : aviptadil)
ZYESAMI (RLF-100 : 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 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 between the two FDA-cleared
protocols (randomized and expanded access). Information on the
RLF-100 Expanded Access Program can be found
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 , which has been awarded FDA Fast Track
designation (previously RLF-100 : 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.