NRx Pharmaceuticals (NASDAQ:NRXP) Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
- NRx Pharmaceuticals achieves data-lock in Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101.
- Anticipated top-line data release in April 2024 after positive results.
- Partners Alvogen, Inc. and Lotus Pharmaceuticals, Inc. to cover future development costs in this indication.
- NRX-101 awarded Breakthrough Therapy Designation and Fast Track Designation by the FDA for treatment of Suicidal Treatment Resistant Bipolar Depression.
- Previous trials show NRX-101's potential for a broader patient population, expanding its market potential.
- NRX-101 demonstrates reduced symptoms of depression and suicidal ideation in patients with bipolar depression.
- FDA suggests exploring NRX-101's applicability to a larger population of patients with subacute suicidality.
- NRx Pharmaceuticals plans to submit a New Drug Application to FDA for the use of ketamine as a short-term therapy for suicidal bipolar depression.
- Successful trial outcomes position NRX-101 as a potential alternative to electroconvulsive therapy for suicidal depression.
- None.
The completion of the data-lock phase in NRx Pharmaceuticals' Phase 2b/3 study is a significant milestone in the development of NRX-101 for Suicidal Treatment Resistant Bipolar Depression. The anticipation of top-line data in April 2024 holds substantial implications for the company's valuation and future revenue streams. Given that NRX-101 has received several FDA designations, such as Breakthrough Therapy and Fast Track, the drug's potential market approval could be expedited, enhancing its commercial prospects.
The promised milestone payments from Alvogen, Inc. and Lotus Pharmaceuticals, Inc., contingent upon positive data, underscore the high stakes involved. The financial infusion of $4 million, followed by the possibility of $320 million in further milestones, not to mention the mid-teen royalties on net sales, could significantly bolster NRx's financial position. This is particularly relevant for investors as it directly impacts the company's cash flow and funding for future development costs.
Furthermore, the expansion of the potential market from hundreds of thousands to several million patients per year, should the broader indication be approved, represents a substantial increase in the addressable market. This could lead to a marked upsurge in the company's stock price, reflecting the market's assessment of the potential future earnings growth.
The reported treatment compliance and concordance rates exceeding 94% are notable, as they surpass the norm for central nervous system (CNS) trials. This high level of adherence to treatment protocols and consistency in rating scales is indicative of robust trial design and execution, which may reduce the risk of data variability and increase the likelihood of obtaining clear efficacy results.
The study's design, which compares NRX-101 to lurasidone and its use of established metrics like the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression Suicidality Scale (CGI-SS), provide a credible framework for evaluating the drug's efficacy. The use of a double-blind methodology is critical in maintaining the objectivity of the trial outcomes, which in turn, is essential for regulatory approval and market acceptance.
The development of NRX-101 as a potential treatment for Suicidal Treatment Resistant Bipolar Depression could mark a paradigm shift in the management of this condition. The current standard treatment involving electroconvulsive therapy has significant limitations and a stigma attached, which underscores the need for more accessible and less invasive treatments. An oral medication like NRX-101 could offer a more acceptable and widespread treatment option, potentially improving patient outcomes and adherence.
Moreover, the ability to treat suicidal ideation within a clinical trial setting is a novel approach that has not been previously explored due to the inherent risks involved. The success of this trial could pave the way for future research in this area, potentially leading to the development of new protocols for the inclusion of high-risk patients in clinical studies. This could have far-reaching implications for the development of treatments for other mental health conditions where suicidal ideation is a factor.
- Data transferred for independent statistical analysis
- Top-line data 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
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
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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