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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