- New data demonstrates no impact of NRX-101 on gut or vaginal
flora – considered primary causes of pseudomembranous colitis
due to C difficile and vaginal yeast infections
- NRX-101 previously demonstrated potent activity against
resistant urinary pathogens and has been shown to be fully
excreted, unmetabolized, in the urine
- NRX-101 has received FDA Qualified Infectious Disease Product
(QIDP) and Fast Track Designation in Complicated Urinary Tract
Infection (cUTI) and Pyelonephritis
RADNOR,
Pa., April 17, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq:NRXP) ("NRx Pharmaceuticals", "NRx",
the "Company"), a clinical-stage biopharmaceutical company, today
announced new data that demonstrate that in a rodent model NRX-101
shows no measurable damage to either intestinal or vaginal flora,
compared to the significant negative effect caused by drugs such
as ciprofloxacin. Antibiotics commonly used to
treat complicated urinary tract infections (cUTI) are associated
with pseudomembranous colitis caused by Clostridium
difficile (C diff) and vaginal yeast infections,
primarily owing to their impact on normal flora.
C. diff causes an intractable diarrhea in approximately
500,000 Americans each year and kills 1 in 11 Americans over age 65
who contract the infection. Costs of C. diff are estimated
at $24,000 per patient and are
significantly higher when C. diff occurs as part of a
hospital admission. Whereas most antibiotics have substantial
effect in the large bowel, the key component of NRX-101
(D-cycloserine) is entirely absorbed in the small intestine and
excreted unmetabolized in the urine. If the nonclinical data
reported today are replicated in patients, NRX-101 could represent
the first antibiotic for cUTI and pyelonephritis that has
essentially no risk of causing C. diff infection or vaginal
yeast infection. There is an extensive literature surrounding the
use of D-cycloserine to treat tuberculosis and cases of C.
Diff are unknown.
D-cycloserine's effect as an antibiotic is based on its
propensity to substitute for the amino acid alanine in the
formation of the bacterial cell wall.
Dr. Michael Manyak, noted Professor of Urology and former
Global Medical Director for Urology at Glaxo SmithKline stated "As
a Urologist, I'm acutely aware of the importance of avoiding common
side effects of current antibiotics. NRX-101's lack of impact on
normal flora could potentially confer a distinct advantage for the
product in for the treatment of cUTI and pyelonephritis. This
profile could change the lives of the half million Americans each
year who contract C. diff and save lives among the tens of
thousands who die from antibiotic-induced C. diff
infections. These potential advantages 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.
"While we have primarily focused on NRX-101 as a drug to treat
CNS disease, these new and highly provocative findings suggest that
NRX-101 could find a home as a first line treatment for cUTI and
pyelonephritis, which afflicts more than 3 million Americans each
year. Should the rodent model findings prove applicable to the
people, the use of NRX-101 to treat cUTI without increasing the
risk of C. diff infection could have multibillion dollar
potential," said Stephen Willard,
JD, Chief Executive Officer of NRx pharmaceuticals.
About D-Cycloserine in cUTI
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. (Lodise TP, et. al. Open
Forum Infectious Diseases
https://doi.org/10.1093/ofid/ofac307)
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, NRX-101 has now been shown to have minimal tendency to
disrupt the microbiome of the intestine and vagina and which can
lead to secondary Clostridium difficile and/or yeast
infections. C. diff associated colitis doubles
hospital mortality and costs the American healthcare system up to
$1.6 billion each year. (Drozd EM,
et. al. Mortality, Hospital Costs, Payments, and Readmissions
Associated With Clostridium difficile Infection DOI:
10.1097/IPC.0000000000000299) Additionally, DCS has no
known association pulmonary fibrosis, a rare, lethal condition that
has been associated with macrolide (tetracycline family)
antibiotics.
NRX-101 has received FDA Qualified Infectious Disease Product
(QIDP) and Fast Track Designations in Complicated Urinary Tract
Infection and Pyelonephritis.
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 and Lotus 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 HTX-100 (IV ketamine), through Hope Therapeutics,
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a
Specialty Pharmaceutical Company, wholly-owned by NRX
Pharmaceuticals focused on development and marketing of an
FDA-approved form of intravenous ketamine for the treatment of
acute suicidality and depression together with a digital
therapeutic-enabled platform designed to augment and preserve the
clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, among others,
statements regarding the proposed public offering and the timing
and the use of the proceeds from the offering. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as "may," "will," "should," "would," "expect,"
"plan," "believe," "intend," "look forward," and other similar
expressions among others. These statements relate to future events
or to the Company's future financial performance, and involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from any
future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. You
should not place undue reliance on forward-looking statements since
they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond the Company's control and
which could, and likely will, materially affect actual results,
levels of activity, performance or achievements. Any
forward-looking statement reflects the Company's current views with
respect to future events and is subject to these and other risks,
uncertainties and assumptions relating to the Company's operations,
results of operations, growth strategy and liquidity. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's most recent Annual Report on Form 10-K and other filings
with the Securities and Exchange Commission. Investors and security
holders are urged to read these documents free of charge on the
SEC's website at http://www.sec.gov. Except as may be required
by applicable law, The Company assumes no obligation to publicly
update or revise these forward-looking statements for any reason,
or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, whether
as a result of new information, future events or otherwise.
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