- Data transferred for independent statistical analysis
- Top-line data expected in April
2024
RADNOR,
Pa., April 8, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that the Company has achieved data-lock in its Phase
2b/3 Suicidal Treatment Resistant
Bipolar Depression Study with NRX-101. With data-lock, as
forecast in last week's earnings call, the complete data set passed
on for statistical analysis; top-line data release expected in
April 2024.
With positive data from this study and FDA comment, NRx becomes
eligible to receive the balance of its first milestone (an
additional $4 million) from partners
Alvogen, Inc. and Lotus Pharmaceuticals, Inc. (1745.TW).
These partners would then be responsible for all future
development costs in this indication. NRx retains rights for
all other indications, including chronic pain and PTSD. NRx
is then poised to receive $320
million in further milestones along with mid-teen royalties
on Net Sales.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast
Track Designation, a Biomarker Letter of Support, and a Special
Protocol Agreement by the FDA for treatment of Suicidal Treatment
Resistant Bipolar Depression. It is the only oral medication to
have demonstrated both reduced symptoms of depression and reduced
suicidal ideation in patients with bipolar depression, a lethal
disease that claims the lives of one in five who live with it.
The previous STABIL-B trial, (Ref. STABIL-B) resulted in the
award of Breakthrough Therapy Designation for the use of NRX-101
following ketamine in hospitalized patients with Severe Bipolar
Depression and Acute Suicidal Ideation and NRx was cleared by FDA
to conduct a phase III trial in this regard under the Special
Protocol Agreement. FDA then suggested that the Company explore
whether NRX-101 might be applicable to the much larger population
of patients with subacute suicidality who are cared for in the
outpatient setting on a chronic basis. The purpose of this trial
was to determine whether a signal could be detected that would
support a much broader indication for NRX-101. Successful data in
this regard would expand the potential market for NRX-101 from
several hundred thousand patients per year to several million
patients per year.
"Patients with active suicidal ideation have been excluded from
the clinical trials of all previously known oral antidepressants.
This trial of NRX-101 is the first under an FDA Investigational New
Drug application to attempt to develop an oral therapy that offers
patients with suicidal bipolar depression an alternative to
electroconvulsive therapy, which is currently the only FDA-approved
therapy for suicidal depression," said Dr. Jonathan Javitt,
Founder, Chairman and Chief Scientist of NRx Pharmaceuticals.
"The Company has also announced plans to submit a New Drug
Application to FDA this quarter for the use of ketamine as a
short-term therapy for suicidal bipolar depression. We believe this
is the first trial to demonstrate that suicidal patients can safely
be enrolled and treated within the context of a clinical trial, and
this was only possible because of the close monitoring of our study
investigators and site personnel. We are deeply appreciative of the
tremendous work done by our clinical development team, the study
sites and, most importantly, the patients who participated in our
trial."
The Phase 2b/3 trial
(www.clinicaltrials.gov NCT 03395392) is a randomized,
prospective, multicenter, double-blind study comparing NRX-101 to
lurasidone over six weeks. The Principal Investigator is
Prof. Andrew Nierenberg of Harvard
Massachusetts General Hospital. The primary efficacy endpoint
is reduction in depression as measured on the Montgomery-Asberg
Depression Rating Scale (MADRS) and the secondary endpoint is
reduction of suicidal ideation as measured by the Clinical Global
Impression Suicidality Scale (CGI-SS). As previously
disclosed, treatment compliance and concordance of local raters to
central raters scores was in excess of 94%, well above the industry
standard that is normally seen in CNS trials.
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 is
developing NRX-101, an FDA-designated investigational Breakthrough
Therapy for suicidal treatment-resistant bipolar depression and
chronic pain. NRx has partnered with Alvogen and Lotus around the
development and marketing of NRX-101 for the treatment of suicidal
bipolar depression. NRX-101 additionally has potential to act as a
non-opioid treatment for chronic pain, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for HTX-100 (IV ketamine), through Hope Therapeutics,
in the treatment of suicidal depression, based on results of
well-controlled clinical trials conducted under the auspices of the
US National Institutes of Health and newly obtained data from
French health authorities, licensed under a data sharing agreement.
NRx was awarded Fast Track Designation for development of ketamine
(NRX-100) by the US FDA as part of a protocol to treat patients
with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a
Specialty Pharmaceutical Company, wholly-owned by NRX
Pharmaceuticals focused on development and marketing of an
FDA-approved form of intravenous ketamine for the treatment of
acute suicidality and depression together with a digital
therapeutic-enabled platform designed to augment and preserve the
clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, among others,
statements regarding the proposed public offering and the timing
and the use of the proceeds from the offering. Forward-looking
statements generally include statements that are predictive in
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include words such as "may," "will," "should," "would," "expect,"
"plan," "believe," "intend," "look forward," and other similar
expressions among others. These statements relate to future events
or to the Company's future financial performance, and involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from any
future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. You
should not place undue reliance on forward-looking statements since
they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond the Company's control and
which could, and likely will, materially affect actual results,
levels of activity, performance or achievements. Any
forward-looking statement reflects the Company's current views with
respect to future events and is subject to these and other risks,
uncertainties and assumptions relating to the Company's operations,
results of operations, growth strategy and liquidity. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's most recent Annual Report on Form 10-K and other filings
with the Securities and Exchange Commission. Investors and security
holders are urged to read these documents free of charge on the
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update or revise these forward-looking statements for any reason,
or to update the reasons actual results could differ materially
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as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.