$RLFTF DD "opinion" post by Ingelr - Key takeaway
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Posted On: 02/09/2021 1:11:33 PM
$RLFTF DD "opinion" post by Ingelr - Key takeaways from Phase 2b/3 trial Initial Data Release
NeuroRx and Relief Therapeutics Report Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ in Reducing Hospital Stay Among Patients with Respiratory Failure due to Critical COVID-19
RADNOR, Pa. and GENEVA, Feb. 9, 2021 /PRNewswire/ -- NeuroRx, Inc.. and Relief Therapeutics Holdings AG (SIX:RLF; OTCQB: RLFTF) today reported preliminary results from the Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) in patients with respiratory failure due to Critical COVID-19.
The study showed that patients who were treated with the maximal standard of care plus ZYESAMI benefited significantly from the treatment, compared to those treated with placebo plus maximal standard of care. If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.
...
Quote:
"The study has not yet determined results for the stated primary endpoint of recovery from respiratory failure."
Preliminary Study Results:
+ Primary endpoint = resolution of respiratory failure within 28 days after treatment started. [On-going assessment].
+ Secondary endpoints = (A) patient survival [Success], (
time to ICU discharge [Success], (C) time to hospital discharge [Success], (D) time to return to NIAID score of 6-8 [Data unavailable], and (E) safety [Success].
+ Standard of care (SOC) treatments including Remdesivir, anti-cytokine drugs, steroids, and anticoagulants.
A total of 138 patients (91 ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65 ZYESAMI, 31 SOC) were discharged from the hospital by Day 28.
Upcoming:
+ Will discuss with FDA submission of an Emergency Use Authorization (EUA).
+ Launched a phase 2/3 trial to explore its inhaled use in patients who are not yet in respiratory failure.
+ Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial.
+ Signed a clinical trial agreement with another federal program the details of which will be announced shortly.
+ Will report on day 60 survival.
+ The first demonstration of clinically and statistically-significant benefit by any therapeutic agent in patients with COVID-19 respiratory failure in a randomized, double-blind, prospective trial.
https://www.biospace.com/article/releases/neu...-covid-19/
NeuroRx and Relief Therapeutics Report Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ in Reducing Hospital Stay Among Patients with Respiratory Failure due to Critical COVID-19
RADNOR, Pa. and GENEVA, Feb. 9, 2021 /PRNewswire/ -- NeuroRx, Inc.. and Relief Therapeutics Holdings AG (SIX:RLF; OTCQB: RLFTF) today reported preliminary results from the Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) in patients with respiratory failure due to Critical COVID-19.
The study showed that patients who were treated with the maximal standard of care plus ZYESAMI benefited significantly from the treatment, compared to those treated with placebo plus maximal standard of care. If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.
...
Quote:
"The study has not yet determined results for the stated primary endpoint of recovery from respiratory failure."
Preliminary Study Results:
+ Primary endpoint = resolution of respiratory failure within 28 days after treatment started. [On-going assessment].
+ Secondary endpoints = (A) patient survival [Success], (
time to ICU discharge [Success], (C) time to hospital discharge [Success], (D) time to return to NIAID score of 6-8 [Data unavailable], and (E) safety [Success]. + Standard of care (SOC) treatments including Remdesivir, anti-cytokine drugs, steroids, and anticoagulants.
A total of 138 patients (91 ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65 ZYESAMI, 31 SOC) were discharged from the hospital by Day 28.
Upcoming:
+ Will discuss with FDA submission of an Emergency Use Authorization (EUA).
+ Launched a phase 2/3 trial to explore its inhaled use in patients who are not yet in respiratory failure.
+ Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial.
+ Signed a clinical trial agreement with another federal program the details of which will be announced shortly.
+ Will report on day 60 survival.
+ The first demonstration of clinically and statistically-significant benefit by any therapeutic agent in patients with COVID-19 respiratory failure in a randomized, double-blind, prospective trial.
https://www.biospace.com/article/releases/neu...-covid-19/
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