Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI(TM) (aviptadil)

Rhea-AI Summary

Relief Therapeutics announced that its U.S. partner, NRx Pharmaceuticals, has submitted a revised Investigational New Drug module for ZYESAMI (aviptadil) to the FDA, confirming Nephron Pharmaceuticals can supply the drug commercially. Additionally, NRx received positive audit results from a European QP Auditor at a separate facility. Relief's lead candidate, RLF-100 (aviptadil), targets respiratory deficiency due to COVID-19 and has undergone late-stage clinical testing.

Positive

• NRx Pharmaceuticals submitted a revised Investigational New Drug module for ZYESAMI to the FDA.
• Nephron Pharmaceuticals is prepared to supply ZYESAMI on a commercial scale.
• Positive audit results from a European Qualified Person Auditor indicate compliance at a manufacturing facility.

Negative

• None.

GENEVA, SWITZERLAND / ACCESSWIRE / October 13, 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 they have submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI(TM) (aviptadil) to the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press release, NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. 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 RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) 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 (iii) 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 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/667866/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-Progress-on-Worldwide-Commercial-Scale-Development-of-ZYESAMITM-aviptadil

FAQ

What is the recent announcement by Relief Therapeutics regarding ZYESAMI (aviptadil)?

Relief Therapeutics announced that NRx Pharmaceuticals submitted a revised Investigational New Drug module for ZYESAMI to the FDA.

What did the FDA report about the manufacturing of ZYESAMI?

The FDA confirmed that Nephron Pharmaceuticals is prepared to supply ZYESAMI on a commercial scale.

What were the results of the European Qualified Person audit for Relief Therapeutics?

The European QP Auditor completed an inspection at a manufacturing facility with no adverse findings.

How is Relief Therapeutics involved in the treatment of COVID-19?

Relief's lead drug candidate, RLF-100 (aviptadil), is in late-stage clinical testing for respiratory deficiency due to COVID-19.

What potential risks are associated with Relief Therapeutics' collaboration with NRx Pharmaceuticals?

There are risks related to the approval of aviptadil for use in the U.S., U.K., or E.U., which may affect Relief's future performance and results.