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EQS-News NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19

Nachrichtenquelle: EQS Group AG
13.10.2020, 07:00  |  4688   |   |   

EQS Group-News: Relief Therapeutics Holdings AG / Key word(s): Study results
NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19

13.10.2020 / 07:00


NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to
critical COVID-19

  • RLF-100(TM) therapy associated with a 9-fold increased probability of survival and recovery from respiratory failure in an open-label, prospective study
  • Top-line data from randomized, placebo-controlled Phase 2b/3 trial expected this quarter

Geneva, Switzerland, and Radnor, PA, October 13, 2020 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc., today announced topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to an intensive care unit (ICU) with critical COVID-19 and respiratory failure were treated with RLF-100(TM)(aviptadil) and compared to 24 control patients treated in the same setting. All patients had severe comorbidities that rendered them ineligible for the ongoing randomized, controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100(TM), and all patients were deteriorating despite treatment with approved therapies for COVID-19.

Overall, 81% of RLF-100(TM)-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100(TM) demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.

"We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results," said Jihad Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study's principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial.

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EQS-News NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19 EQS Group-News: Relief Therapeutics Holdings AG / Key word(s): Study results NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for …

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