Relief Reports that U.S. Collaboration Partner has Announced a New Finding from Aviptadil Phase 2b/3 Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19

Rhea-AI Summary

Relief Therapeutics announced new findings from the phase 2b/3 trial of ZYESAMI (aviptadil) by its U.S. partner, NRx Pharmaceuticals, indicating significant improvements in blood oxygen levels in patients with acute respiratory failure due to COVID-19. This analysis may support NRx's application for Breakthrough Therapy Designation from the FDA, which could streamline the drug's pathway to market. Relief's collaboration with NRx aims to address the unmet needs in treating critically ill patients, enhancing its position in the biopharmaceutical landscape.

Positive

• Significant improvement in blood oxygen levels in patients treated with ZYESAMI within one day.
• Potential application for Breakthrough Therapy Designation could expedite regulatory review.

Negative

• The outcome of the FDA application remains uncertain.

GENEVA, SWITZERLAND / ACCESSWIRE / August 31, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (" NRx "), has issued a press release announcing an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI(TM) (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. This latest analysis also appears to support NRx's plan to submit an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration for this indication. Relief believes that, if granted, this could confer Priority Review to the aviptadil New Drug Application, when submitted. The related NRx press release can be accessed through the following link .

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 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. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA 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 . Follow us on LinkedIn.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether Relief can resolve its ongoing dispute with NRx without litigation, (iii) whether aviptadil will ever be approved in the U.S., UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iv) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA 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

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FAQ

What are the latest findings from Relief Therapeutics' collaboration with NRx Pharmaceuticals regarding aviptadil?

Recent findings indicate that aviptadil treatment resulted in significant improvements in blood oxygen levels for patients with acute respiratory failure due to COVID-19.

What is the significance of Breakthrough Therapy Designation for aviptadil?

Breakthrough Therapy Designation could expedite FDA review, potentially leading to quicker access for patients in need.

When was the new data regarding aviptadil reported?

The new data was reported on August 31, 2021, in conjunction with the phase 2b/3 clinical trial results.

How does the new analysis impact Relief Therapeutics’ future?

The new analysis may enhance investor confidence and support the company's strategy in addressing critical health needs in COVID-19 treatment.