02 June 2021
Geneva, Switzerland, June 2, 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 COVID-19-induced respiratory disorders, reported today that its collaboration partner, NRx Pharmaceuticals, Inc. (formerly known as: NeuroRx Pharmaceuticals, Inc.), has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking Emergency Use Authorization (EUA) for the use of aviptadil in the treatment of critical COVID-19 in patients with respiratory failure. NRx’s press release announcing its EUA submission can be accessed through the following link.
“We are delighted that our partner has submitted aviptadil for EUA and look forward to a decision by the Agency,” said Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “Despite the increase in the number of people being fully vaccinated against COVID-19, with emerging variants and disparities in vaccination rates, there remains a major need for effective therapeutic options for patients with respiratory failure. We are excited about the potential aviptadil holds in helping critical COVID-19 patients and are hopeful that the drug candidate will soon be available to those who remain in need of better treatments.”
Dr. Selvaraju continued: “We would also like to take this opportunity to not only congratulate our partner on completing the EUA submission but also on their recent listing on Nasdaq.”
The EUA submission is based on the results of a COVID-19 IV randomized, placebo-controlled phase 2b/3 clinical trial conducted by NRx in the United States. Relief also confirms that it has received a copy of the clinical study report from this trial from NRx and looks forward to pursuing the best path forward for the development of IV RLF-100 in Europe and other territories.
FDA’s guidance to industry identifies the criteria for EUA as safe and “may be effective,” in contrast to the far more stringent requirement of “safe and effective” required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true for the COVID-19 pandemic. There is no guidance or regulation regarding how quickly FDA will review EUA applications.
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 development 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.
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance that NRx's application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.