- First investigational drug for patients with Severe Bipolar
Depression and Acute Suicidal Ideation/Behavior, a high unmet
medical need
- Company received Breakthrough Therapy Designation and a Special
Protocol Assessment ("SPA") for this trial helping to mitigate
risks and accelerate the timing of this NRX-101 development
program
- First trial site has been contracted with others expected in
near future, first dosing of patients is expected in early
2023
- Company to meet with research analysts and investors in
conjunction with the upcoming JP Morgan Healthcare Conference
RADNOR,
Pa., Jan. 3, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that its first clinical trial site has been contracted
(with others expected in near future) and that first dosing of
patients is expected in early 2023. This Phase 3 clinical trial of
NRX-101 is for the treatment of Severe Bipolar Depression with
Acute Suicidal Ideation and Behavior ("SBD-ASIB"), a lethal
condition that currently takes the lives of thousands of Americans
each year. NRX-101 is the first investigational medicine to target
this condition, for which the only currently approved treatment is
Electroconvulsive Therapy.
Based on preliminary efficacy demonstrated in the Company's
Phase 2 STABIL-B trial1, the FDA awarded
Breakthrough Therapy Designation to NRX-101 in 2018. The Company
subsequently received an FDA agreement for the Phase 3 trial under
a Special Protocol Assessment which indicated that "based on the
information submitted [FDA] agrees that the design and planned
analysis of your study adequately address the objectives necessary
to support a regulatory submission."
To strengthen compliance, the Company is using electronic
compliance monitoring. Additionally, the Company will perform
independent internal confirmation of depression and suicidality
ratings as was done in the STABIL-B trial. In that prior trial,
these methods enabled a high compliance with study medication and
high concordance between the psychometric ratings ascertained at
study sites and those confirmed by the Company's team of
psychometric raters.
A Type B meeting with the FDA's Psychiatry Division is scheduled
in mid-January 2023. The purpose of
this meeting is to align on the registration strategy for NRX-101
in the initial indication for treatment of adults with
SBP-ASIB.
Mr. Stephen Willard, JD, CEO of
NRx stated, "As we continue to lose lives to suicide, there is no
approved medicine to treat suicidal bipolar depression. Somewhere
in America, a person attempts suicide every 27 seconds. We at NRx
aim to replicate by year end a positive risk/benefit in our Phase 3
study as was achieved in the STABIL-B trial. We look forward to our
meetings with research analysts and investors in conjunction with
the upcoming JP Morgan Healthcare Conference."
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 and Government Affairs
mcogan@nrxpharma.com
INVESTOR RELATIONS
Suzanne Messere
Investor Relations
suzanne.messere@sternir.com
1Nierenberg, et. al
https://www.medrxiv.org/content/10.1101/2022.08.11.22278658v1.full
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SOURCE NRx Pharmaceuticals, Inc.