- The Independent Data Safety Monitoring Board identified no
safety concerns and issued a recommendation to continue trial
enrollment.
- No treatment-related Serious Adverse Events with first 50
enrolled clinical trial participants
RADNOR,
Pa., Feb. 2, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx
Pharmaceuticals", the "Company"), a clinical-stage
biopharmaceutical company, today reported the recommendations of an
independent Data Safety Monitoring Board (DSMB) which reviewed the
safety findings of the first fifty enrolled participants in the
Company's phase 2 clinical trial of NRX-101 for the treatment of
Severe Bipolar Depression and Subacute Suicidal Ideation or
Behavior (www.clinicaltrials.gov NCT NCT03395392). NRX-101 is a
proprietary fixed dose combination of D-cycloserine and
lurasidone. It is the only antidepressant currently in
clinicals trials for patients with Bipolar Depression with acute or
sub-acute suicidality, which also entails an NMDA component,
similar to AUVELITY® and SPRAVATO®.
The Independent Data Safety Monitoring
Board identified no safety concerns and issued a recommendation to
continue trial
Unlike the Company's previously completed Phase 2 study which
enrolled acutely suicidal patients, this current Phase 2 study
addresses the needs of the much larger population of patients with
bipolar depression and sub-acute levels of suicidality, i.e., not
requiring stabilization in a clinical setting, who are cared for in
the outpatient setting, including doctors' offices, community
mental health centers, and outpatient clinics. The Company's
Bipolar Depression with Acute Suicidal Ideation or Behavior (ASIB)
study requires that patients first be stabilized in a clinical
setting, patients enrolled in this current Phase 2 trial are
randomly assigned to NRX-101 or lurasidone – a widely used drug
indicated for the treatment of bipolar depression.
The DSMB recommended that enrollment in the trial continue as
planned and identified no drug-related Serious Adverse Events or
other safety issues of concern. The Company anticipates that the
DSMB will examine unblinded study data in March 2023 to assess the study for safety,
potential futility, and conditional power. The Company views
today's safety finding as important because this is the first time,
to the Company's knowledge that patients with bipolar depression
and subacute suicidal ideation and behavior (i.e., present with an
ideation score at a screening of 3 or 4 on the Columbia Suicide
Severity Rating Scale (CSSR-S)) have been actively recruited into
an outpatient clinical trial of a novel NMDA based
antidepressant.
Mr. Stephen Willard, JD, Chief
Executive Officer of NRx Pharmaceuticals stated, "In today's
environment, there is no approved medicine to treat suicidal
bipolar depression. Somewhere in America, someone attempts suicide
every 27 seconds. We appreciate the DSMB's work in guiding us to
continue this trial. We are now exploring a registrational
path forward to serve this much larger group of individuals with
bipolar depression and subacute levels of suicidality. This
population of patients
encompasses a much larger proportion of the approximately 7
million individuals in America who have bipolar disease, half of
whom are reported to attempt suicide at some point in their
lives."
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.commailto:
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-reports-recommendations-of-data-safety-monitoring-board-for-trial-of-nrx-101-in-patients-with-severe-bipolar-depression-and-subacute-suicidal-ideation-or-behavior-301736992.html
SOURCE NRx Pharmaceuticals, Inc.