EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Keyword (s): Miscellaneous
02.06.2021 / 07:00
Relief Therapeutics Announces that its Collaborative Partner, NRx Pharmaceuticals, Has Submitted an Application for Emergency Use of Aviptadil to the United States Food & Drug Administration
Geneva, Switzerland, June 2, 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 respiratory disorders induced by COVID-19, today announced that its collaborative partner, NRx Pharmaceuticals, Inc. (formerly known as: NeuroRx Pharmaceuticals, Inc.), announced that it has submitted an application to the United States Food and Drug Administration (FDA) for 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 viewed via the following link connect.
“We are delighted that our partner has submitted aviptadil for EUA and look forward to a decision from the Agency,” said Raghuram (Ram) Selvaraju, chairman of the Relief Council. “Despite the increase in the number of people fully vaccinated against COVID-19, with emerging variants and disparities in vaccination rates, there remains a major need for effective treatment options for patients with respiratory failure. We are excited about the potential of aviptadil. helping critical COVID-19 patients and hopefully the drug candidate will soon be available for those who still need better treatments. “
Dr Selvaraju continued, “We would also like to take this opportunity to congratulate our partner not only for completing the EUA submission, but also for their recent listing on Nasdaq. “
The EUA’s submission is based on the results of a randomized, placebo-controlled Phase 2b / 3 clinical trial of COVID-19 IV conducted by NRx in the United States. Relief also confirms that it has received a copy of the clinical study report for this NRx trial and looks forward to pursuing the best way forward for the development of IV RLF-100 in Europe and other territories.
FDA guidance to industry identifies the EUA criteria as safe and “may be effective”, in contrast to the much more stringent requirement of “safe and effective” required for the approval of traditional drugs. The EUA can only be granted in circumstances where the Secretary of Health and Human Services has declared a public health emergency, as is the case with the COVID-19 pandemic. There are no guidelines or regulations regarding how quickly the FDA will review EUA applications.
Relief primarily focuses on clinical stage programs based on molecules with a history of clinical trials and use in human patients or strong scientific rationale. The lead drug candidate for Relief RLF-100MT (aviptadil), a synthetic form of vasoactive intestinal peptide (VIP), is in advanced clinical development in the United States for the treatment of respiratory impairment 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 global development and commercialization of ACER-001. ACER-001 is a patented, taste-masked, immediate-release powder formulation of sodium phenylbutyrate (NaPB) for the treatment of urea cycle disorders and maple syrup disease.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and listed in the United States on the OTCQB under the symbol RLFTF. For more information visit www.relieftherapeutics.com.
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Warning: This communication expressly or impliedly contains certain forward-looking statements regarding RELIEF THERAPEUTICS Holding AG, and there can be no assurance that NRx’s EUA application will be approved by the FDA or that Relief will be successful in obtaining product approval in Europe or elsewhere. territories. Such statements involve certain risks, uncertainties and other known and unknown factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from the future results, performance or achievements expressed. or implied by these futures contracts. forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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