- Company receives notice of the issuance of a U.S. patent
covering the lead formulation, NRX-101, a glycine site NMDA
antagonist in clinical trials to treat bipolar depression with
acute and subacute suicidality;
- This new patent represents a third patent family, that now
totals 48 issued patents worldwide with 42 additional pending
patent applications.
- Patent covers the use of NRX-101 to treat patients suffering
from depression, including bipolar depression or major depression
(MDD) with or without suicidality and strengthens the Company's
intellectual property position until at least 2033;
- Upon approval of NRX-101, this newly granted patent is expected
to be "listable" in the U.S. Food and Drug Administration (FDA)
Orange Book.
RADNOR,
Pa., Feb. 22, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx
Pharmaceuticals", the "Company"), a clinical-stage
biopharmaceutical company, today announced that the U.S. Patent and
Trademark Office ("USPTO") has issued U.S. Patent No.
11,576,911.
NRx Pharmaceuticals Builds on Its
Intellectual Property Foundation for Neuropsychiatric
Conditions-Adds New U.S. Patent
This patent, issued to Glytech LLC, is exclusively licensed to
NeuroRx, Inc. ("NeuroRx"), a wholly owned subsidiary of NRx, under
the terms of a license agreement with Glytech through which NeuroRx
has the sole rights to this and other patents, both U.S. and
international. The licensed patents cover certain
pharmaceutical formulations and their uses in treating a variety of
neuropsychiatric conditions, including bipolar depression, major
depressive disorder, PTSD, and suicidality.
In particular, the claims of the new patent cover methods for
treating a patient suffering from depression, including bipolar
depression or major depression, with or without suicidality by
administering to the patient an effective amount of the Company's
lead product candidate, NRX-101. Should this drug candidate be
approved by the U.S. Food & Drug Administration ("FDA"), this
newly issued patent is expected to be listable in the FDA's "Orange
Book" for NRX-101, which is currently undergoing clinical trials in
the U.S. The 'patent represents the U.S. version of a third patent
family owned by or exclusively licensed to NeuroRx that covers the
NRX-101 formulation or its methods of use in treating depressive
disorders, and such patent coverage is expected to remain in force
through at least July 2033 prior to
any patent term extensions available under federal law. Previously
issued patents cover the NRX-101 composition of matter and methods
for preventing akathisia, a common side effect of SSRI
antidepressants.
"The grant of this new patent augments the strength of NRx
Pharmaceuticals' intellectual property, which consists of about 90
patents and patent applications globally," said Stephen Willard, Chief Executive Officer of NRx
Pharmaceuticals. "It validates the novelty or our science and
highlights its potential importance in bringing lifesaving
treatments to patients with life-threatening neuropsychiatric
conditions, including depression and PTSD."
In 2023, the company expects to have additional patents granted
from its pending portfolio and to file more patent applications in
the U.S. and internationally.
About NRX-101
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 bipolar depression and acute suicidal ideation & behavior
(ASIB) remains electroconvulsive therapy (ECT).
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 PTSD and other
indications. To date, NRX-101 is the only oral NMDA investigational
medicine focused on bipolar depression in patients with acute and
sub-acute suicidality.
About NRx
Pharmaceuticals
Clinical-stage biopharmaceutical company developing therapeutics
for the treatment of central nervous system disorders, specifically
suicidal depression and post-traumatic stress disorder (PTSD). The
company's lead program NRX-101, an oral, fixed-dose combination of
D-cycloserine and lurasidone, targets the brain's NMDA receptor and
is being investigated in a Phase 3 trial under an FDA Special
Protocol Agreement and Breakthrough Therapy Designation in patients
with bipolar depression and suicidal ideation, an indication for
which the only approved treatment is electroshock therapy. NRx
Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute
Suicidality, a substantially broader indication. The Breakthrough
Therapy Designation and Special Protocol Agreement were awarded by
the FDA based on the Company's prior STABIL-B trial that
demonstrated substantial improvement over available therapy in
reducing depression and suicidality compared to placebo when
patients were treated with NRX-101 after a single dose of
ketamine.
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.
CORPORATE CONTACT
Molly Cogan
Sr. Director, Global Communications
mcogan@nrxpharma.com
INVESTOR RELATIONS
Suzanne Messere
Investor
Relations
suzanne.messere@sternir.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-builds-on-its-intellectual-property-foundation-for-neuropsychiatric-conditions---adds-new-us-patent-to-portfolio-301752767.html
SOURCE NRx Pharmaceuticals, Inc.