- NRX-101 has demonstrated potent activity against resistant
urinary pathogens upon FDA review
- QIDP designation grants Priority Review and an additional 5
years of additional product exclusivity
- 3 million Americans develop complicated Urinary Tract
Infection (cUTI) each year at a cost that ranges from $4497 to $17,431
with a high rate of antibiotic resistance and need for inpatient
hospitalization1
- Unlike many advanced-generation antibiotics, NRX-101 is not
contra-indicated in sulfa and penicillin allergic patients and is
not believed to disrupt the normal intestinal microbiome,
potentially leading to reduced risk of C. difficile
infection
- Data have been accepted for posting on biorxiv and are
under review at a peer-reviewed journal3
RADNOR,
Pa., Jan. 16, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that it has received Qualified Infectious Disease Product
(QIDP) and Fast Track designation from the US FDA for NRX-101 in
the treatment of complicated urinary tract infections (cUTI) and
pyelonephritis. Receipt of QIDP designation confers Priority
Review, and critically, five additional years of data-exclusivity
to NRX-101's already strong Intellectual Property position.
The FDA also granted NRX-101 Fast Track designation for cUTI, which
additionally allows for rolling submission of the Company's New
Drug Application. In addition to the marketplace protections
conferred by QIDP designation in the US, NRx has composition of
matter patent protection on NRX-101 through at least 2033 in all
major global markets. The data that formed the basis of FDA's QIDP
approval have been submitted for publication. On the basis of this
advance, NRx is seeking partners with active involvement in
urology, infectious disease and/or women's health for
commercialization of NRX-101.
The active antibiotic ingredient of NRX-101 is D-cycloserine
(DCS) that was developed as an antibiotic in the 1950's and used
worldwide for the treatment of tuberculosis. However, it fell out
of favor with the development of trimethoprim/sulfa and various
penicillins, cephalosporins, and tetracyclines, in part because of
the CNS effects associated with DCS-induced blockade of the brain's
NMDA receptor. In the course of its CNS research, NRx
pharmaceuticals has demonstrated that small doses of lurasidone
counteract those CNS effects, potentially providing a new
therapeutic life to DCS as an antibiotic. Over the ensuing decades,
increased antibiotic resistance has rendered standard treatments
for UTI ineffective in many cases and today 3 million Americans
suffer from cUTI requiring increasingly toxic antibiotics,
increasingly frequent intravenous therapy, and increased need for
hospital admission.1
Because DCS has the unique property of being highly
concentrated, unmetabolized, in the urine with oral administration,
the Company believes, and previous literature has suggested that
DCS may effectively treat, and therefore help prevent, the need for
intravenous and inpatient treatment of cUTI. Moreover, because DCS
is rapidly absorbed and excreted in the urine, the Company is
optimistic that NRX-101 will have a minimal tendency to disrupt the
microbiome of the intestine and which can lead to secondary
Clostridium difficile infection. C. diff
associated colitis doubles hospital mortality and costs the
American healthcare system up to $1.6
billion each year.2 Additionally, DCS has
no known association with C. diff or with pulmonary fibrosis, a
rare, lethal condition that has been associated with macrolide
(tetracycline family) antibiotics.
"When we embarked on the development of NRX-101 for treating
bipolar depression, we did not imagine that it would develop a new
utility as a potentially lifesaving antibiotic. However, the
antibiotics we have relied upon for decades are increasingly
failing to control resistant pathogens and those that are able to
do so are increasingly toxic. NRx thanks the US FDA for its rapid
award of QIDP designation for cUTI and pyelonephritis. These
conditions impact 3 million Americans annually and can carry
significant co-morbidities, including sepsis and death," said Dr.
Jonathan Javitt, Founder, Chairman
and Chief Scientist of NRx Pharmaceuticals." Whereas the 12 million
Americans who contract uncomplicated UTI each year can expect rapid
relief from well-known antibiotics, those who contract cUTI
frequently require intravenous therapy, and hospitalization, with
frequent serious side effects"
Dr. Michael Manyak, noted
Professor of Urology and former Global Thought Leader for Glaxo
SmithKline's urology business added "As a Urologist, I am excited
about the potential availability of NRX-101 for patients suffering
from cUTI; this is a very serious condition in desperate need of
new treatment options. Receipt of QIDP and Fast Track should
make NRX-101 even more attractive to potential partners in this
multi-billion-dollar market." Dr. Manyak serves as NRx's Medical
Thought Leader for urology.
The data presented to the FDA have now been accepted for posting
on the biorxiv pre-print server and are under review by a
peer-reviewed journal.3
About NRx Pharmaceuticals
NRx Pharmaceuticals is a
clinical-stage biopharmaceutical company developing therapeutics
based on its NMDA platform for the treatment of central nervous
system disorders, specifically suicidal bipolar depression, chronic
pain and PTSD. The Company is developing NRX-101, an FDA-designated
investigational Breakthrough Therapy for suicidal
treatment-resistant bipolar depression and chronic pain. NRx has
partnered with Alvogen Pharmaceuticals around the development and
marketing of NRX-101 for the treatment of suicidal bipolar
depression. NRX-101 additionally has potential to act as a
non-opioid treatment for chronic pain, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for ketamine in the treatment of suicidal depression,
based on results of well-controlled clinical trials conducted under
the auspices of the US National Institutes of Health and newly
obtained data from French health authorities, licensed under a data
sharing agreement. NRx was awarded Fast Track Designation for
development of ketamine (NRX-100) by the US FDA as part of a
protocol to treat patients with acute suicidality.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995, which may include, but are not limited to, statements
regarding our financial outlook, product development, business
prospects, and market and industry trends and conditions, as well
as the Company's strategies, plans, objectives, and goals. These
forward-looking statements are based on current beliefs,
expectations, estimates, forecasts, and projections of, as well as
assumptions made by, and information currently available to, the
Company's management.
The Company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise. Accordingly, you should not place reliance on any
forward-looking statement, and all forward-looking statements are
herein qualified by reference to the cautionary statements set
forth above.
1 Lodise TP, et. al. Open Forum Infectious
Diseases https://doi.org/10.1093/ofid/ofac307
2 Drozd EM, et. al. Mortality, Hospital
Costs, Payments, and Readmissions Associated With Clostridium
difficile Infection DOI: 10.1097/IPC.0000000000000299
3 https://doi.org/10.1101/2024.01.14.575572
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