RELIEF CONFIRMS RELEASE OF 60-DAY FINDINGS FROM PHASE 2B/3 CLINICAL TRIAL OF INTRAVENOUS RLF-100™ (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™ (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™ by its partner NeuroRx, Inc.
According to NeuroRx, across all patients and sites, RLF-100™ 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™ 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™ 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.
For further information, please refer to NeuroRx’s press release which can be accessed through the following link.
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.