- Ketamine, an NMDA blocker, was highly effective in Bipolar
subgroup (p<0.001)
- NRx plans to present the data to FDA with a goal of
identifying a path to an NDA
RADNOR,
Pa., Sept. 15, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that it has signed a data sharing agreement with the
study leadership of a randomized, placebo-controlled trial of 156
patients hospitalized for Acute Suicidality and Depression in 7
French Government Hospitals.
This trial, conducted under International Good Clinical
Practices and Helsinki standards
demonstrated a dramatic and statistically-significant reduction in
suicidal ideation and depression (P<.0001) among patients
randomized to intravenous racemic ketamine, compared to those
randomized to placebo. The trial reached its primary endpoint for
all patients and demonstrated the largest effect among the subgroup
with bipolar depression (84% vs 28% remission, drug vs. placebo;
p<0.0001; Odds ratio 14).
The top line data from this trial were published in the British
Medical Journal
(BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194) and
additional data reports are planned. The efficacy
demonstrated confirms earlier, smaller trials conducted in
the United States and
elsewhere.
As disclosed previously, NRx met with the FDA in January 2023 at which time the FDA requested
randomized, placebo-controlled data in support of intravenous
ketamine for acute suicidality in the inpatient setting. Such
trials are extraordinarily complex to organize and generally
require Government support. In this case, NRx approached the
Fondation FundaMental, led by Prof. Marion
Leboyer, MD, PhD, who served on the NRx Scientific Advisory
Board and facilitated establishing the current Data Sharing
Agreement.
Under this agreement, NRx has translated the clinical study
report, which will be submitted to FDA and is converting the
electronic, patient level data files to a form suitable for FDA
review. NRx plans to meet with FDA in the coming months to
discuss a regulatory path for the use of ketamine to treat patients
with Bipolar Depression and Acute Suicidal Ideation and
Behavior.
"We at NRx are honored that the study leadership has agreed to
share these landmark data so that they may be submitted to and
reviewed by the US FDA," said Dr. Jonathan
Javitt, Founder and Chief Scientist of NRx Pharmaceuticals.
"We look forward to a fruitful ongoing collaboration with Prof.
Abbar and his study team leadership for the benefit of patients
everywhere."
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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