Four Near-Term Milestones Expected in 2023/Early 2024 for NRx Pharmaceuticals
Key Highlights :
NRx Pharmaceuticals, Inc. (Nasdaq: ) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter ended and provided a business update. The Company has four upcoming milestones that have the potential to unlock substantial shareholder value.
The first milestone is completing enrollment of the originally-targeted 70 patients in the Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression (TRBD). Enrollment is expected to continue through November to increase study power. The target population is based on the Company's meeting with the FDA in which the Company was guided to expand its intended use of NRX-101 from the original population of patients with acute suicidality to the broader population of patients with subacute suicidal ideation. The Company has contracted with 1nHealth to initiate a recruitment campaign that may cover up to 45 states in the U.S. to recruit sufficient participants for this enlarged trial. The Company has similarly broadened its relationship with Science 37, a contract research organization that conducts clinical trials, to enroll participants identified by the 1nHealth recruitment initiative and randomize them to be treated within the broadened clinical trial. The Company has additionally engaged "The Mighty," a voice-of-the-patient organization with national reach to publicize the clinical trial to the 800,000+ subscribers who have indicated a focus on bipolar depression and suicidality.
The second milestone is the completion of manufacturing for phase 3/commercial stage investigational product. The Company has completed manufacture of all clinical supplies required for its ongoing clinical trials. This initiative is expected to yield stability data sufficient to support a shelf life in excess of two years at time of potential drug launch (should the clinical trials be successful). The completion of this manufacturing milestone may allow the Company to decrease ongoing expenditure associated with manufacturing and development of chemical manufacturing controls. Product stability work has continued to support the targeted two-year shelf life at potential drug launch.
The third milestone is the initiation of potential spinout initiatives. During Q3, the Company has solidified its working relationship with Alvogen and begun working in unison to plan the final development and commercialization of NRX-101. As previously announced, a successful readout from this trial and FDA interaction will trigger a milestone payment from Alvogen together with transfer of future development costs to our partner. Based on milestones achieved during this quarter, the NRX-101 project is on track for completion of a pivotal trial in coordination with a commercial stage partner in less than two years from its re-initiation in at the tail of the COVID pandemic to its projected readout.
The fourth milestone is the Department of Defense (DOD) -funded clinical trial of DCS for chronic pain. The Company has previously detailed the scientific basis for treatment of chronic pain with DCS as outlined in a 2016 scientific paper published by Schnitzer, et. al. and in the White Paper posted by the Company's Scientific Leadership ( ). In the second quarter, the Company licensed US Patent 8,653,120 for the use of DCS in chronic pain and filed a now-accepted Investigational New Drug (IND) application with the FDA to initiate commercial drug development of NRX-101 in chronic pain. Chronic pain affects more than 50 million American adults, compared to the approximately 3 million who report thoughts of suicide on an annual basis. There has been no new non-opioid class of drugs to treat nociceptive pain in the past two decades and NRX-101 has the potential to be the first N-methyl-D-aspartate (NMDA)-antagonist drug to seek approval for this indication. Today, ketamine is used off label to treat nociceptive pain, despite its clear limitations (addiction, neurotoxicity, hallucination, and the need for IV administration.) The Company awaits results of a 200-person randomized prospective trial funded by the US DOD (NCT 03535688) in which patients with chronic pain were randomly assigned to DCS 400mg/day vs. placebo. The investigators have identified primary completion of this trial as occurring in , with top-line results. Should these results support efficacy of DCS in the treatment of chronic low back pain, they are expected to provide a Breakthrough Therapy designation for NRX-101.
These four upcoming milestones have the potential to unlock substantial shareholder value for NRx Pharmaceuticals. The Company is approaching its clinical trial enrollment goals for its partnered foundation product NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. Achieving any one of these milestones has the potential to unlock exponential growth, and the Company is working hard to make sure that all four of these initiatives are successful.
