Relief Reports that its U.S. Collaboration Partner has Announced the U.S. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil

Rhea-AI Summary

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received notice from the FDA denying Breakthrough Therapy Designation for aviptadil. While this designation could have expedited the review process, it is not a requirement for drug approval. The FDA had previously granted priority and rolling review under Fast Track Designation. NRx emphasized that potential approval remains viable, but acknowledges the need for improved scientific alignment. Relief continues to advance its clinical programs, including RLF-100 for COVID-19 respiratory issues.

Positive

• NRx Pharmaceuticals retains the opportunity to secure approval for aviptadil despite the denial of BTD.
• FDA's Fast Track Designation grants priority and rolling review for aviptadil.
• Relief continues to pursue diverse clinical programs, including RLF-100 for respiratory issues.

Negative

• Denial of Breakthrough Therapy Designation may slow the review process for aviptadil.

Geneva, Switzerland, November 24, 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, 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. (Nasdaq: NRXP) (" NRx "), has issued a CEO Update announcing that the U.S. Food and Drug Administration (" FDA ") has denied Breakthrough Therapy Designation (" BTD ") for aviptadil. NRx noted that BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with the sponsor. Additionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020. Therefore, the denial does not impede NRx's ability to seek drug approval, although it does identify areas where NRx needs to seek better scientific alignment with the FDA. The related NRx CEO Update 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

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https://www.accesswire.com/674545/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-the-US-Food-and-Drug-Administration-has-Denied-Breakthrough-Designation-for-Aviptadil

FAQ

What happened with aviptadil's FDA Breakthrough Therapy Designation on November 24, 2021?

The FDA denied the Breakthrough Therapy Designation for aviptadil, although this does not prevent NRx Pharmaceuticals from seeking drug approval.

What does the FDA's denial of BTD mean for Relief Therapeutics and its stock RLFTF?

The denial indicates that while aviptadil can still be approved, the absence of BTD may result in a lengthier review process.

How does the FDA's Fast Track Designation affect aviptadil?

Aviptadil has been granted Fast Track Designation, allowing for priority and rolling review, which can still facilitate the approval process.

What is the current status of Relief Therapeutics' lead drug candidate RLF-100?

RLF-100 (aviptadil) is in late-stage clinical testing for respiratory deficiency due to COVID-19.