- NRX-101 demonstrated potent antibacterial effect against
antibiotic-resistant pathogens in culture medium and in an
artificial urine model
- D-cycloserine (DCS), a key component of NRX-101, was
originally developed as an anti-infective in the 1950's but was
replaced by antibiotics that have since lost effectiveness against
complicated Urinary Tract Infections (cUTI)
- In an era when 90% of cUTI pathogens demonstrate resistance
to standard antibiotics, NRX-101 may prove effective in treating
cUTI and preventing urosepsis
RADNOR,
Pa., Sept. 6, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced new data that demonstrate potent in vitro activity
of NRX-101 (D-cycloserine + lurasidone) against reference strains
of Urinary Tract pathogens known to cause complicated urinary tract
infections (cUTIs). D-cycloserine (DCS) was originally
developed as an anti-infective in the 1950's but was never labeled
for treatment of UTI, because of the prevalent and then-effective
use of common antibiotics. In recent years, however, cUTI is
increasingly caused by pathogens that are resistant to common
antibiotics and are increasingly likely to cause sepsis, a lethal
condition. Approximately 17,000 deaths per year in the United States are attributed to
genitourinary sepsis.1 The study, commissioned
by NRx at Charles River Laboratories, is consistent with
previously reported academic studies that demonstrate potency of
DCS in antibiotic-resistant strains of urinary pathogens.
![(PRNewsfoto/NRx Pharmaceuticals) (PRNewsfoto/NRx Pharmaceuticals)](https://mma.prnewswire.com/media/1734122/NRX_Logo_Logo.jpg)
"These newly-obtained data from an internationally-recognized
research organization demonstrate that NRX-101 has a potent level
of in-vitro activity against dangerous pathogens, such as
Pseudomonas and Acinetobacter. DCS was eclipsed by common
antibiotics in the 1950s, partly because of the rarity of such
pathogens at the time and the effectiveness of first and second
generation antibiotics against the common urinary tract pathogens
of the day. DCS additionally had an early history of causing mild
hallucinations in some patients, although it remains widely used by
the World Health Organization. In the studies conducted by NRx and
others with DCS in combination with lurasidone and similar drugs,
these CNS side effects have not been observed. At the same time,
the fourth generation antibiotics that are now used to treat cUTI
are increasingly associated with systemic side effects." said Dr.
Jonathan Javitt, Founder and Chief
Scientist of NRx Pharmaceuticals, Inc. "DCS has the advantage
of being highly concentrated in the urine, suggesting that NRX-101
has potential to be developed as a safe and effective treatment of
cUTI."
If successfully developed, NRX-101 could offer cUTI patients an
effective therapy with a favorable safety profile. Because NRx has
already completed the phase 3 manufacture of NRX-101, the Company
is in a position to immediately seek investigational human use for
this indication, while continuing to develop NRX-101 for suicidal
depression and chronic pain.
Complicated UTI is increasingly common in the US, with an
estimated 3 million new diagnoses annually.2
Antibiotic resistance is common as well.3 While
the CNS effect of DCS is based on its inhibition of the brain's
NMDA receptor, Cycloserine also inhibits cell-wall synthesis in
various bacteria.
About NRX-101
NRX-101, a fixed dose combination of D-cycloserine and
lurasidone, has been granted Fast Track Designation, Breakthrough
Therapy Designation, a Special Protocol Agreement, and a Biomarker
Letter of Support from the FDA for S-TRBD. Additionally, the
product is being developed in chronic pain and PTSD.
Up to 50% of individuals with bipolar disorder attempt suicide
over their lifetime, and estimates indicate that up to 20% may
succumb to suicide. The only FDA-approved treatment for patients
with treatment-resistant suicidal bipolar depression remains
electroconvulsive therapy.
Conventional antidepressants can increase the risk of suicide in
certain patients; hence their labels contain a warning to that
effect. NRX-101 is a patented, oral, fixed dose combination of
D-cycloserine and lurasidone, neither of which has shown addiction
potential in preclinical models. Based on the results of a Phase 2
proof-of-concept study, NRX-101 received Breakthrough Therapy
Designation from the FDA for the treatment of severe bipolar
depression in patients with ASIB after initial stabilization with
ketamine or other effective therapy.
NRX-101 is one of the first oral antidepressants currently in
late-stage clinical studies targeting the NMDA-receptor in the
brain, which represents potentially a key new mechanism to treat
depression with and without suicidality, as well as chronic pain,
PTSD and other indications.
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's
lead program NRX-101, an oral, fixed-dose combination of
D-cycloserine and lurasidone, targets the brain's
N-methyl-D-aspartate (NMDA) receptor and is being investigated in a
Phase 2b/3 clinical trial for
suicidal treatment-resistant bipolar depression (S-TRBD), which
includes patients with both acute and sub-acute suicidality, an
indication for which the only approved treatment is electroshock
therapy. The Company has partnered with Alvogen Pharmaceuticals,
who owns the worldwide rights to NRX-101 for treatment of S-TRBD,
to help bring NRX-101 to a global population of patients with unmet
medical need. NRx Pharmaceuticals is currently exploring NRX-101's
potential to act as a non-opioid chronic pain treatment option and
is continuing to plan to enroll patients in an Israeli-based trial
of patients suffering from post-traumatic stress disorder with
depression and 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.
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Prest J, Nguyen T,
Rajah T, Prest AB, Sathananthan M, Jeganathan N. Sepsis-Related
Mortality Rates and Trends Based on Site of Infection. Crit Care
Explor. 2022 Oct 10;4(10):e0775. doi: 10.1097/CCE.0000000000000775.
PMID: 36248320; PMCID: PMC9556121.
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Carreno JJ, Tam IM,
Meyers JL, Esterberg E, Candrilli SD, Lodise TP, Jr. Longitudinal,
nationwide, cohort study to assess incidence, outcomes, and costs
associated with complicated urinary tract infection. Open Forum
Infect Dis 2020; 7:ofz536
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Open Forum
Infectious Diseases, Volume 9, Issue 7, July 2022,
ofac315
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SOURCE NRx Pharmaceuticals, Inc.