Relief Reports U.S. Collab. Partner Announces Filing Breakthrough Therapy Request for Aviptadil in Pts at Immediate Risk of Death from COVID-19 Despite Treatment w/Remdesivir, Other Approved Therapies

Rhea-AI Summary

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, has filed for Breakthrough Therapy Designation from the FDA for aviptadil aimed at treating COVID-19 patients experiencing respiratory failure. The BTD request is supported by clinical data showing a 2.8-fold increase in survival odds at 28 days and a 4-fold increase at 60 days for patients treated with aviptadil compared to a placebo. This data may significantly impact Relief's market position and investor sentiment regarding its ongoing clinical programs.

Positive

• Filing for Breakthrough Therapy Designation may accelerate approval timeline for aviptadil.
• Clinical data indicates significant survival benefits from aviptadil treatment.

Negative

• Approval of aviptadil remains uncertain due to potential risks and FDA's requirements.
• Dependence on collaboration partner NRx for pivotal clinical advancements.

GENEVA, SWITZERLAND / ACCESSWIRE / December 30, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("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 collaboration partner, NRx Pharmaceuticals, Inc. (NRXP) ("NRx"), has announced it has filed for a new Breakthrough Therapy Designation ("BTD") request with the U.S. Food and Drug Administration ("FDA") focused on patients with Critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with Remdesivir and other approved therapies. According to the press release, the BTD request is based on an FDA request for clinical data on the effectiveness of aviptadil compared to Remdesivir and other approved therapies. The press release also reported patients treated with aviptadil vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60 and a highly significant (P=.006) four-fold increased odds of survival is seen in these patients. 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 symbols RLFTF and RLFTY. 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 aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and 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 does 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/680177/Relief-Reports-US-Collab-Partner-Announces-Filing-Breakthrough-Therapy-Request-for-Aviptadil-in-Pts-at-Immediate-Risk-of-Death-from-COVID-19-Despite-Treatment-wRemdesivir-Other-Approved-Therapies

FAQ

What is the recent FDA filing by Relief Therapeutics related to?

Relief Therapeutics announced that NRx Pharmaceuticals filed for a Breakthrough Therapy Designation for aviptadil to treat COVID-19 patients with respiratory failure.

What clinical results support the FDA filing for aviptadil?

The filing is based on data showing a 2.8-fold increase in survival odds at 28 days and a 4-fold increase at 60 days for patients treated with aviptadil compared to placebo.

What are the potential impacts of the FDA filing on RLFTF and RLFTY stock?

The filing could improve market sentiment and potentially drive stock prices higher if aviptadil receives favorable FDA approval.