- "Study May Proceed" letter received from FDA
- Potential to initiate registrational study in
2024
RADNOR,
Pa., Dec. 18, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company today
announced that its Investigational New Drug Application (IND) for
the use of NRX-101, the company's patented combination of
D-cycloserine and lurasidone, for the treatment of complicated
Urinary Tract infections (cUTI), received clearance from the US
FDA.
"Complicated Urinary Tract Infections afflict approximately 3
million Americans each year, and pathogens have become increasingly
resistant to commonly used antibiotics. New treatment options are
urgently needed" stated Jonathan Javitt, MD MPH, Founder and
Chief Scientist of NRx Pharmaceuticals. "The D-cycloserine
(DCS) component of NRX-101 is well known as an antibiotic and is
excreted unmetabolized in the urine. However, the NMDA-antagonist
effects of DCS led to its disuse in the
United States, while it has remained a widely used
anti-tuberculosis agent by the World Health Organization. NRx's
patented discovery that combining DCS with small amounts of
lurasidone counters the CNS side effects potentially and renders
NRX-101 an important, patented antibiotic, just at a time when
Americans are increasingly facing intravenous antibiotic therapy
and even hospitalization and death from pathogens that were readily
controlled a generation ago. This mission is personal to me, in
that I have lost two close friends, one the father of a founding
investor, to sepsis from urinary infections that were readily
controlled a generation ago."
As previously disclosed, the company sees the greatest value for
this program in an independent company dedicated to the development
and commercialization of NRX-101 for cUTI. Because the
manufacturing phase of NRX-101 is complete, the Company has secured
Composition of Matter patent protection, and the Company has
commercial-grade drug product on hand, this initiative is not
expected to require additional investment in R&D prior to
clinical trials. Accordingly, the company is developing plans to
spin out a new company, much like the planned spin-out of Hope
Therapeutics to develop NRX-100 (IV Ketamine) for suicidal
depression, where NRx, existing shareholders (through a share
dividend), and new investors will own the company.
NRx has recruited Michael Manyak,
MD, as Lead Clinical Advisor for this initiative. Prof. Manyak is
an internationally-recognized urologist who trained at leading
universities and the US National Institutes of Health. Most
recently, he served as the Global Medical Affairs Director for the
GlaxoSmithKline urology franchise and the Chief Medical Advisor for
Crisis Response for Accenture. He is an Adjunct Professor of
Urology and Engineering and former Professor of Immunology,
Microbiology, and Tropical Medicine at The George Washington University (GWU). He is a member
of the Baylor College of Medicine
National School of Tropical Medicine.
"At a time when routine use of standard antibiotics demonstrates
increasing resistance and failure to control urinary tract
infections, I believe it is vital to advance safe, oral antibiotics
for complicated UTI that have the potential to avoid the need for
intravenous therapy, to keep patients out of the hospital, and to
save lives," said Dr. Manyak. "I look forward to learning whether
the efficacy we demonstrated for NRX-101 in the laboratory against
some of the most resistant bacteria can be replicated in
patients."
The company awaits the FDA's response to its request for
Qualified Infectious Disease Product (QIDP) designation, expected
next month.
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.
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 press release 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. Actual results
could differ materially from those contemplated by the
forward-looking statements. A discussion of these and other
factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K,
as may be supplemented, or amended by the Company's Quarterly
Reports on Form 10-Q. Given these risks, uncertainties, and
factors, you are cautioned not to place undue reliance on such
forward-looking statements, which are qualified in their entirety
by these cautionary statements.
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.
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SOURCE NRx Pharmaceuticals, Inc.