RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that its first clinical trial site has recently been contracted (with others expected in near future) and that first dosing of patients is expected in early 2023. This Phase 3 clinical trial of NRX-101 is for the treatment of Severe Bipolar Depression with Acute Suicidal Ideation and Behavior (“SBD-ASIB”), a lethal condition that currently takes the lives of thousands of Americans each year. NRX-101 is the first investigational medicine to target this condition, for which the only currently approved treatment is Electroconvulsive Therapy.
Based on preliminary efficacy demonstrated in the Company’s Phase 2 STABIL-B trial1, the FDA awarded Breakthrough Therapy Designation to NRX-101 in 2018. The Company subsequently received an FDA agreement for the Phase 3 trial under a Special Protocol Assessment which indicated that “based on the information submitted [FDA] agrees that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission.”
To strengthen compliance, the Company is using electronic compliance monitoring. Additionally, the Company will perform independent internal confirmation of depression and suicidality ratings as was done in the STABIL-B trial. In that prior trial, these methods enabled a high compliance with study medication and high concordance between the psychometric ratings ascertained at study sites and those confirmed by the Company’s team of psychometric raters.
A Type B meeting with the FDA’s Psychiatry Division is scheduled in mid-January 2023. The purpose of this meeting is to align on the registration strategy for NRX-101 in the initial indication for treatment of adults with SBP-ASIB.
Mr. Stephen Willard, JD, CEO of NRx stated, “As we continue to lose lives to suicide, there is no approved medicine to treat suicidal bipolar depression. Somewhere in America, a person attempts suicide every 27 seconds. We at NRx aim to replicate by year end a positive risk/benefit in our Phase 3 study as was achieved in the STABIL-B trial. We look forward to our meetings with research analysts and investors in conjunction with the upcoming JP Morgan Healthcare Conference.”
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