- Marks a major step in the development of what could be the
first drug approved for Suicidal Bipolar Depression
- The study database is being cleaned and locked; statistical
analysis and top-line data to follow shortly thereafter
- Study maintained 95% concordance rate between study sites and
central raters on primary endpoint. No unexpected Serious Adverse
Events were reported.
- Positive data and FDA comment would trigger the next
$4 million milestone payment from
partners Alvogen and Lotus and their assumption of development
costs; agreement provides for up to $329
million in milestone payments and a royalty on Net Sales in
the mid-teens
RADNOR,
Pa., March 4, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that the 74th and last evaluable patient has
completed their day 42 visit in its Phase 2b/3 study of
NRX-101, the Company's patented combination of the NMDA antagonist
D-cycloserine and lurasidone, in Suicidal Treatment Resistant
Bipolar Depression. The database is being cleaned, finalized,
and locked; statistical analysis will then be performed, with
top-line data to follow shortly thereafter. As previously
disclosed, positive data from this trial triggers a milestone
payment from Alvogen. Alvogen will then be responsible for further
development and commercialization costs for this program.
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 bipolar
depression. It is the only oral medication to have demonstrated
reduced suicidal ideation in patients with bipolar depression, a
lethal disease that claims the lives of one in five who live with
it.
"This is the first clinical trial, to the company's knowledge,
conducted among patients with suicidal bipolar depression in the
outpatient setting. Our previous trial measured the ability of
NRX-101 to maintain the anti-depressant and anti-suicidal effect of
ketamine administered in the hospital setting. These patients,
whose clinical need is urgent and extraordinary have routinely been
excluded from the clinical trials of all previously-known
anti-depressant drugs. said Dr. Jonathan Javitt, Founder,
Chairman and Chief Scientist of NRx Pharmaceuticals. Although
there were patients whose depression worsened and required
hospitalization (we don't yet know whether they were on NRX-101 or
comparator), patient safety was maintained, and no trial
participant suffered a serious unexpected adverse outcome. Our
thanks go out to our investigators, clinics, partners and, most
importantly, our amazing patients and their families for seeing
this study through to this important milestone," "
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 MADRS scale 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.
Top-line results are expected around the end of this
quarter.
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.
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should not place undue reliance on forward-looking statements since
they involve known and unknown risks, uncertainties and other
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forward-looking statement reflects the Company's current views with
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the realization of forward-looking statements is set forth in the
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SOURCE NRx Pharmaceuticals, Inc.