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Wednesday, December 30, 2020

Relief, NeuroRx Conclude Enrollment in Critical Covid Treatment Phase 2b/3 Trial

 RELIEF

THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("*Relief*" or the 
"*Company*") and NeuroRx, Inc. today announced the conclusion of enrollment 
in the phase 2b/3 trial of ZYESAMI(TM) (previously RLF-100TM: aviptadil) for 
the treatment of Respiratory Failure in patients with Critical COVID-19 
(www.clinicaltrials.gov [1] NCT04311697). No drug-related serious adverse 
events have been reported as of today. Enrollment was increased from 165 
patients in order to amass as large a safety database as possible. Top line 
data are expected in late January - early February 2021. 
 
"With FDA's authorization and the extraordinary dedication of our twelve 
clinical trial sites, we were able to take a drug not formulated or 
administered to patients in IV form since 2005 and advance it to the clinic 
in ten weeks. We hope that the highly encouraging results seen in the most 
critically-ill COVID-19 patients treated in our expanded access program can 
be replicated in patients who have Critical COVID-19 without an advanced 
comorbidity" said *Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc*. 
"The FDA did not agree to grant EUA, as applied for in September, based upon 
the open-label study reported earlier, but has advised us that they remain 
committed to working with us in the development of our product and will 
promptly review the forthcoming data from this randomized trial. Until that 
time, available stocks of ZYESAMITM (RLF-100TM) will continue to be 
administered under our Expanded Access Protocol and individual patient 
requests under _Right to Try_ laws." 
 
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief*, said: "We 
congratulate NeuroRx on the successful completion of patient enrollment in 
this crucial pivotal clinical study and look forward to the top line 
results. Our fervent hope is for RLF-100TM to bring benefit to critically 
ill patients suffering the consequences of COVID-19 infection."
https://www.marketscreener.com/quote/stock/RELIEF-THERAPEUTICS-HOLDI-5527488/news/EQS-News-Relief-and-NeuroRx-Conclude-Enrollment-in-their-Phase-2b-3-Trial-of-RLF-100-TM-for-Criti-32100012/

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