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EQS-News Relief Confirms Release of 60-Day Findings from Phase 2b/3 Clinical Trial of Intravenous RLF-100(TM) (aviptadil)

Nachrichtenquelle: EQS Group AG
30.03.2021, 07:00  |  281   |   |   

EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Study
Relief Confirms Release of 60-Day Findings from Phase 2b/3 Clinical Trial of Intravenous RLF-100(TM) (aviptadil)

30.03.2021 / 07:00


Relief Confirms Release of 60-Day Findings from Phase 2b/3 Clinical Trial of Intravenous RLF-100(TM) (aviptadil)

60-day results have been presented by Relief's partner, NeuroRx, Inc.

Geneva, Switzerland, March 30, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"), a biopharmaceutical company with its lead compound RLF-100(TM) (aviptadil) in advanced clinical development to treat critically-ill COVID-19 patients, today announced the release of 60-day results from the phase 2b/3 trial of intravenously administered RLF-100(TM) by its partner NeuroRx, Inc.

According to NeuroRx, across all patients and sites, RLF-100(TM) met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site. The prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, RLF-100(TM) patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). 84% of HFNC patients treated at tertiary medical centers with RLF-100(TM) survived to day 60 compared with 60% of those treated with placebo (P = .007).

On the basis of these findings, NeuroRx confirmed plans to apply immediately to the United States Food and Drug Administration for Emergency Use Authorization and to subsequently submit a New Drug Application.

Once the full data set has been obtained, Relief will reach out to European regulators to present the outcomes of the Phase 2b/3 clinical trial. A European Phase 2b/3 clinical trial is planned to be initiated later this year.

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EQS-News Relief Confirms Release of 60-Day Findings from Phase 2b/3 Clinical Trial of Intravenous RLF-100(TM) (aviptadil) EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Study Relief Confirms Release of 60-Day Findings from Phase 2b/3 Clinical Trial of Intravenous RLF-100(TM) (aviptadil) 30.03.2021 / 07:00 Relief Confirms Release of 60-Day Findings …

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