· The independent Data Safety Monitoring
Board recommended continuation of patient enrollment as planned
· No safety or futility signals were
reported in the first 50 patients
· This patient population could represent
up to 1 million bipolar depression patients in the US and
represents a portion of the indication expansion recommended in
recent correspondence with the FDA
· Trial has been upgraded to a Phase
2b/3 study that may be used for a
registrational filing
RADNOR,
Pa., March 27, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx
Pharmaceuticals", the "Company"), a clinical-stage CNS
biopharmaceutical company, today reported that the
independent Data Safety Monitoring Board (DSMB) reviewed the safety
and efficacy findings of the first fifty enrolled participants in
the Company's 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. The people enrolled in this trial had
bipolar depression and suicidal thoughts. They were being treated
in the outpatient setting. Going forward, NRx will use the term
"Suicidal Treatment-Resistant Bipolar Depression" to describe this
potential indication.
The DSMB found no futility signal at this stage of the trial.
Similarly, no safety signals were identified in association with
NRX-101 and the DSMB recommended that enrollment in the trial
continue as planned. According to the study's statistical
analysis plan, the failure to identify futility requires that a
numerical advantage of the investigational drug relative to the
comparator treatment must be observed by the DSMB. The DSMB will
continue to monitor safety and efficacy in the trial.
Based on the DSMB findings, together with the recent completion
of Phase 3/ anticipated commercial stage manufacture of NRX-101,
the Company has upgraded the ongoing trial to a phase 2b/3 trial whose results may be used in a future
registrational filing, should the primary endpoint be met. We
expect top-line data from this trial in the fourth quarter of
2023. In the Type B meeting conducted with the FDA, the
Company was guided to explore the use of NRX-101 in this broader
population of patients who may benefit from NRX-101 without prior
use of ketamine. The Company plans to discuss the path to
approval in this population of people with Suicidal Treatment
Resistant Bipolar Depression in the planned Comprehensive
Breakthrough Therapy Meeting with FDA that is planned for the
second quarter of 2023.
NRX-101 is the first oral NMDA-targeted medicine to be developed
for patients with suicidal bipolar depression. Moreover, this
trial, together with the phase 3 trial for which the Company has
been granted a Special Protocol Agreement by FDA, represent the
only known clinical trials in which patients with active suicidal
ideation or behavior have been enrolled. All known previous studies
of oral antidepressants have excluded patients with active
suicidality. There is reason to believe that people with
bipolar depression may derive particular benefit from NMDA-targeted
drugs, based on a recent trial in France demonstrated that ketamine, a potent
NMDA-targeted drug, may be seven-fold more effective in reducing
suicidal ideation in people with bipolar depression compared
to those with major depressive disorder. Unlike ketamine, however,
NRX-101 is an oral medicine for home use that has been shown not to
be neurotoxic, not to produce psychedelic effects in prior studies,
and to have no potential for addiction in standard screening
tests.
In the US alone, nearly 1 million people are believed to have
Treatment-Resistant Bipolar Depression, a lethal condition that
ultimately leads to a suicide attempt in half of those with bipolar
disorder. Currently, there is no approved medicine for patients
with this condition and the only FDA-approved treatment is
electroshock therapy, which has numerous known side-effects. To
date, no drug-related Serious Adverse events have been identified
in clinical trials of NRX-101.
NRx Pharmaceuticals' CEO Stephen
Willard said: "We are encouraged by the DSMB's advice to
continue this trial in patients with Suicidal Treatment-Resistant
Bipolar Depression, who represent an extraordinary unmet medical
need. The crisis of suicide in our society demands action
now, with an American attempting suicide every 27 seconds. We are
committed to investigating NRX-101 as a potential solution for
this crisis. While all known trials of oral antidepressants
have excluded patients with suicidal ideation, we have embraced
them and – so far – demonstrated that they can be safely welcomed
into a clinical trial of a medicine that may provide benefit. Now
that we have a manufactured inventory of Phase 3/commercial stage
NRX-101, we have upgraded this trial to a Phase 2b/3 registrational study. Additionally, we
are opening an Expanded Access Program as required for all
Breakthrough Therapy Medicines to make this investigational
medicine more broadly available and to accrue the safety database
previously requested by the FDA."
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 medicine, NRX-101, is an oral, fixed-dose combination of
D-cycloserine and lurasidone. NRX-101 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. 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.
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SOURCE NRx Pharmaceuticals, Inc.