NRx Pharma Reports US National Institutes Of Health Study Of Its ZYESAMI for COVID Cleared To Complete Full Enrollment

 

– After review of more than 448 enrolled patients in ACTIV-3b Critical Care Study, no new safety concerns identified by Independent Data Safety Monitoring Board; study cleared to continue enrollment to 640 Patients
– ZYESAMI® (aviptadil) is the sole remaining investigational medicine in ACTIV-3b with recent closures of other arms
– ACTIV-3b Critical Care Study is evaluating ZYESAMI and Veklury® (remdesivir), in Critical COVID-19 Patients, as monotherapy and in combination against placebo
– ACTIV-3b Trial to commence enrollment in Brazil, EU, UK, and Scandinavia in the coming months

RADNOR, Pa., Feb. 15, 2022 /PRNewswire/ — NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage, biopharmaceutical company, today announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) on February 14, 2022. The DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial1. The TESICO protocol was submitted by NIH and cleared by the US Food and Drug Administration (FDA) as a Phase 3 trial that, if positive, may be used in the submission of a New Drug Application for ZYESAMI®.

 

ACTIV-3b is a randomized, placebo-controlled clinical trial testing ZYESAMI and Veklury® ((remdesivir, NASDAQ:GILD) — alone and in combination — in hospitalized patients with acute respiratory failure due to COVID-19. The patients enrolled in TESICO are critically-ill patients in the ICU who have exhausted other approved therapies and require high-flow nasal oxygen, mechanical ventilation, or extracorporeal membrane oxygenation to maintain blood oxygen.

At a September 2021 Reagan Udall Foundation conference chaired by Dr. Francis Collins, former Director of the NIH and Dr. Janet Woodcock, Acting Commissioner of the FDA, Dr. Collins identified ZYESAMI® as one of a handful of investigational compounds selected by the NIH for Phase 3 study from among 600 candidate compounds initially considered.2 Last week, the NIH announced the discontinuation of the PF-07304814 arm of the ACTIV-3 trial on account of futility3 According to an NIH spokesperson, aviptadil is the sole remaining investigational medicine being offered within the ACTIV-3 trial, which targets the most critically-ill patients with COVID-19.4

While the continuation of this trial certainly does not guarantee success in proving the primary endpoint, NRx is encouraged to reach this level of enrollment without identifying either a safety or futility stopping point. Some of the underlying experimental hypotheses in the trial and the statistical power available at the projected study enrollment to prove those hypotheses will be presented in future corporate updates. Next week, NRx investigators will present the first peer-reviewed findings from the Company’s Phase 2b/3 clinical trial, completed in March 2021.5 These data were reviewed by the NIH as part of its decision to select ZYESAMI for inclusion in ACTIV-3b.

NRx further confirms that it has received no reports of drug-related Serious Adverse Events from the NIH and is forwarding this safety information to the FDA for inclusion in its ongoing review. These findings increase the safety database of patients treated with ZYESAMI to more than 800 patients.

At the DSMB meeting, it was noted  that recruitment into the aviptadil arms of the study is ahead of recruitment into the other arms and may potentially be completed in a matter of months patients to the. The Company views this recruitment by physicians at the TESICO study sites as an encouraging sign.The ACTIV-3b trial has now enrolled 448 Critical COVID-19 patients, representing more than 80% of the targeted recruitment. NIH is now moving forward to bring the ACTIV-3b protocol to Brazil, the European Union, the United Kingdom, and Scandinavia. NRx has manufactured investigational medicine to the standards required in those jurisdictions and reported in September 2021 that it passed a European Qualified Person (QP) audit related to that drug supply.  NRx expects to complete regulatory requirements to export ZYESAMI to those regions for investigational use in the coming weeks.

“With more than 80% of the trial enrolled, we are highly encouraged that the Data Safety and Monitoring Board has continued enrollment and that trial investigators have continued to express enthusiasm for enrolling patients into the ZYESAMI arm of the trial at some of the nation’s most advanced hospitals,” said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. “So far, we have received no reports of drug-related Serious Adverse Events in ZYESAMI-treated patients and are sharing those data with the FDA. We are indebted to the NIH leadership for its decision to include our investigational medicine in the ACTIV program alongside investigational medicines from major pharmaceutical companies and hope that ZYESAMI will soon become an important therapeutic option that enables physicians to offer a renewed chance at life to patients who have exhausted all approved therapies.”

 

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