- NRx has Licensed US Patent 8,653,120 for use of
D-Cycloserine to treat Chronic Pain
- Dr. Vania Apkarian, a world
leader in pain and D-Cycloserine (DCS) research, has joined the NRx
Scientific Advisory Board
RADNOR,
Pa., Aug. 7, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced it has made key advances in developing NRX-101 to treat
Chronic Pain.
The Company has signed a License Agreement for US Patent
8,653,120 that claims the use of D-cycloserine for the treatment of
chronic pain in exchange for a commitment to pay milestones and
royalties as development milestones are reached in the field of
chronic pain. The patent is supported by extensive nonclinical data
and early clinical data that suggest the potential for NMDA
antagonist drugs, such as NRX-101 to decrease both chronic pain and
neuropathic pain while potentially decreasing craving for opioids.
Additional published non-clinical data previously reported
demonstrate that NRX-101 is not neurotoxic1 and not
addictive.2
NRx has signed an agreement with Dr. Vania Apkarian, Professor of Physiology,
Anesthesia, Surgery, and Neuroscience Institute, Northwestern University Feinberg School of Medicine
to join the NRx Pharmaceuticals Scientific Advisory Board
(SAB). Over his career, Dr. Apkarian has been devoted to
unravelling brain mechanisms that underlie acute and chronic pain,
and more generally how the brain dynamically processes information
that gives rise to perception. This has included important research
into the use of D-cycloserine in Chronic Pain.
"We delighted welcome Dr. Apkarian to the NRx SAB," said
Jonathan Javitt, Chief Scientist and
Founder of NRx Pharmaceuticals. "Adding a scientist of Vania's
caliber will be invaluable to advancing our clinical program in
Chronic Pain."
NRX-101 Indication – Chronic Pain
- In June 2023, the Company
announced a focus on chronic pain as the next focus on NRX-101's
development.
- DCS has been shown to modulate the Pain Pathway at each point
in the chain: pain transmission
at dorsal horn of the spinal cord, pain perception in the thalamus
("paleo brain"), and pain memory and processing between the paleo
brain and the cortex.
- In experimental mouse models and clinical studies, NMDA
antagonists have demonstrated attenuation of pain and shown
potential in reducing opioid craving. Additionally, DCS has
demonstrated no potential for addiction, unlike ketamine, NMDA
antagonists and opioids.
- Chronic pain is estimated to be a $60
billion industry today with the potential to grow to a
$120 billion industry by 2033.
- D-cycloserine was evaluated in a pilot study at Northwestern University, which showed efficacy at
the higher dose levels in the study.3 DCS is currently
being examined in a confirmatory trial (n>200) in lower back
pain at Northwestern
University.4 Data are expected shortly.
- Research conducted by NRx Pharmaceuticals demonstrated a 25
μg/ml dose at which d-cycloserine becomes an NMDA antagonist. The
400mg dose presented in the confirmatory trial at Northwestern University is at the lower end of the
threshold and suggests that the ability to increase the
d-cycloserine dose beyond 400mg, where lurasidone is used to
prevent CNS side effects.
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.
- Jordan W, Sapko MT, Siegel R, Javitt J. NRX-101, a Rapid-Acting
Anti-Depressant, Does Not Cause Neurotoxicity Following Ketamine
Administration in Preclinical Models. Int J Toxicol.
2023:10915818231176971. 10.1177/10915818231176971
- Sapko MT, Hanania T, Chang Q, Javitt JC. D-cycloserine is not
susceptible to self-administration using an intravenous
self-administration model in male ketamine-habituated
Sprague-Dawley rats. Pharmacol Biochem Behav.
2023;227-228:173586. 10.1016/j.pbb.2023.173586
- Schnitzer TJ, Torbey S, Herrmann K, Kaushal G, Yeasted R,
Vania Apkarian A. A randomized
placebo-controlled pilot study of the efficacy and safety of
D-cycloserine in people with chronic back pain. Mol Pain.
2016;12. 10.1177/1744806916678627
- D-cycloserine for the Treatment of Chronic, Refractory Low Back
Pain.
https://classic.clinicaltrials.gov/ct2/show/NCT03535688.
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SOURCE NRx Pharmaceuticals, Inc.