Relief Reports that its U.S. Collaboration Partner has Announced it has Received a U.S. Food and Drug Administration Review of Aviptadil Manufacturing Information

Rhea-AI Summary

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received a positive response from the U.S. FDA regarding updated manufacturing information for aviptadil. This allows for high-volume production and extends the shelf life of aviptadil from 62 days to 150 days. Relief's lead drug candidate, aviptadil, aims to treat respiratory deficiency in COVID-19 patients and is in late-stage clinical testing. The company also has a diverse development pipeline following recent acquisitions.

Positive

• FDA approval for high-volume production of aviptadil.
• Shelf life of aviptadil extended from 62 days to 150 days.
• Lead drug candidate aviptadil is in late-stage clinical testing for COVID-19.

Negative

• Uncertainty regarding the future approval of aviptadil in the U.S., U.K., or E.U.

GENEVA, SWITZERLAND / ACCESSWIRE / November 12, 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 receipt of the U.S. Food and Drug Administration's (FDA) response to NRx's October 8, 2021 submission of updated manufacturing information for aviptadil. According to the press release, the FDA review allows for high volume production of aviptadil. The press release also reports that the shelf life of aviptadil has been extended from 62 days to 150 days. 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 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/672535/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-it-has-Received-a-US-Food-and-Drug-Administration-Review-of-Aviptadil-Manufacturing-Information

FAQ

What recent FDA decision affects Relief Therapeutics (RLFTF)?

The FDA has approved high-volume production of aviptadil and extended its shelf life.

What is aviptadil and what is its significance for Relief Therapeutics (RLFTF)?

Aviptadil is Relief's lead drug candidate, currently in late-stage clinical testing for treating respiratory deficiency due to COVID-19.

How has Relief Therapeutics (RLFTF) diversified its pipeline?

Relief has diversified its pipeline through acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH.

What is the current status of aviptadil's development by Relief Therapeutics (RLFTF)?

Aviptadil is undergoing late-stage clinical testing in the U.S. for respiratory issues related to COVID-19.