NRX-101 Phase 2b/3 Data Lock Achieved for Suicidal Bipolar Depression Trial

NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals") has announced the completion of data collection for its Phase 2b/3 clinical trial evaluating NRX-101 for Suicidal Treatment Resistant Bipolar Depression. With this milestone, the entire data set is now ready for independent statistical analysis and the results are anticipated to be released in April 2024.

Pending positive outcomes and feedback from the FDA, NRx Pharmaceuticals will receive an additional $4 million from its partners, Alvogen, Inc. and Lotus Pharmaceuticals, Inc., who will subsequently handle all further development expenses for this indication. Additionally, NRx Pharmaceuticals retains rights to develop NRX-101 for other purposes, such as chronic pain and PTSD, and stands to gain $320 million in additional milestones, along with mid-teen royalties based on net sales.

NRX-101 has received several accolades from the FDA, including Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement for treating Suicidal Treatment Resistant Bipolar Depression. To date, it is the only oral medication proving to reduce both depressive symptoms and suicidal thoughts in bipolar depression patients, a condition fatal for one out of five sufferers.

The prior STABIL-B trial earned the Breakthrough Therapy Designation for NRX-101 following ketamine treatment in severely bipolar depressive patients with acute suicidal ideation. Following this, the FDA permitted NRx Pharmaceuticals to proceed with a Phase III trial under the Special Protocol Agreement. The FDA also suggested exploring NRX-101's applicability for outpatients who experience chronic subacute suicidality. This trial aimed to determine if NRX-101 shows potential for a broader use case. If successful, the market for NRX-101 could expand from 100,000's to millions of patients each year.

Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, noted the uniqueness of this trial as the first FDA Investigational New Drug application that seeks to develop an oral therapy aimed at patients with suicidal bipolar depression, offering an alternative to electroconvulsive therapy, currently the only FDA-approved method. Dr. Javitt also shared that the company plans to submit a New Drug Application for ketamine as a short-term therapy for suicidal bipolar depression. He acknowledged the safe enrollment and treatment of suicidal patients within the clinical trial, attributing the success to the diligent monitoring by the study investigators and site personnel.

The trial in question is a six-week, randomized, prospective, multicenter, double-blind study comparing NRX-101 with lurasidone. Led by Principal Investigator Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital, the primary endpoint is the reduction of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), while the secondary endpoint is the reduction of suicidal ideation assessed using the Clinical Global Impression Suicidality Scale (CGI-SS). Compliance and concordance rates exceeded 94%, a figure significantly higher than the industry standard for CNS trials.

NRx Pharmaceuticals is dedicated to developing NMDA-based therapeutics for central nervous system disorders such as suicidal bipolar depression, chronic pain, and PTSD. The company collaborates with Alvogen and Lotus on developing and marketing NRX-101 for bipolar depression that involves suicidality. Additionally, NRX-101 shows promise as a non-opioid chronic pain treatment.

Lastly, NRx Pharmaceuticals plans to submit a New Drug Application for IV ketamine (HTX-100) through its subsidiary, Hope Therapeutics, to treat suicidal depression. The application is based on conclusive clinical trial data and fast-track development status awarded by the FDA.