Relief Therapeutics Reports that Collaboration Partner, NRx Pharmaceuticals, has Announced Additional Results from the Aviptadil U.S. Expanded Access Protocol for Patients with Critical COVID-19

Rhea-AI Summary

Relief Therapeutics Holding AG (OTCQB: RLFTF) reported on June 16, 2021, that its collaboration partner, NRx Pharmaceuticals, announced results from the U.S. Expanded Access Protocol (EAP) for the drug RLF-100 (aviptadil). The EAP involved 240 ICU patients with critical COVID-19 respiratory failure. NRx intends to submit these findings as "real world" evidence to the FDA, supporting earlier clinical trial results. Relief focuses on clinical-stage programs, with RLF-100 in late-stage development for COVID-19 and a collaboration for the treatment of Urea Cycle Disorders.

Positive

• NRx Pharmaceuticals reported results from the Expanded Access Protocol involving 240 ICU patients, supporting aviptadil's efficacy.
• RLF-100 is in advanced clinical development, focusing on COVID-19 respiratory disorders, indicating potential market relevance.

Negative

• There are no guarantees that NRx's application for Emergency Use Authorization (EUA) will be approved by the FDA.
• Relief faces uncertainties regarding obtaining product approval in Europe and other regions.

GENEVA, SWITZERLAND / ACCESSWIRE / June 16, 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 COVID-19-induced respiratory disorders, reported today that its collaboration partner, NRx Pharmaceuticals, Inc., (NRXP) ("NRx") has announced additional results from the aviptadil U.S. Expanded Access Protocol (EAP). The EAP included 240 patients in the intensive care unit (ICU) with critical COVID-19 respiratory failure requiring either invasive or non-invasive mechanical ventilation, or high flow rate oxygen bynasal cannula, and not eligible for the recently completed phase 2b/3 clinical trial with IV aviptadil. According to NRx's press release, these EAP data are being submitted by NRx to the U.S. Food and Drug Administration (FDA) as "real world" evidence in support of the findings from the phase 2b/3 trial. The related NRx press release can be accessed through the following link.

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ABOUT RELIEF

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-100^TM (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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CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer
Mail: contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke
Tel.: +49 (0) 211-529-252-22
Mail: relief@mc-services.eu

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.

SOURCE: Relief Therapeutics Holdings AG

View source version on accesswire.com:
https://www.accesswire.com/651924/Relief-Therapeutics-Reports-that-Collaboration-Partner-NRx-Pharmaceuticals-has-Announced-Additional-Results-from-the-Aviptadil-US-Expanded-Access-Protocol-for-Patients-with-Critical-COVID-19

FAQ

What are the recent developments regarding RLFTF's aviptadil?

Relief Therapeutics' partner NRx Pharmaceuticals announced results from the U.S. Expanded Access Protocol for aviptadil, involving 240 ICU patients.

How is RLFTF's aviptadil related to COVID-19 treatment?

Aviptadil, under the development by Relief, is aimed at treating COVID-19-induced respiratory disorders.

What is the significance of the Expanded Access Protocol for RLFTF?

The Expanded Access Protocol provides real-world evidence supporting aviptadil's efficacy to the FDA.

What risks does RLFTF face in regulatory approvals?

Relief Therapeutics could face challenges in gaining FDA approval for aviptadil's Emergency Use Authorization and approvals in other regions.