Relief Reports that its U.S. Collaboration Partner has Filed a New Breakthrough Therapy Designation Request for Aviptadil
Relief Therapeutics announced that its partner, NRx Pharmaceuticals, has filed for Breakthrough Therapy Designation with the FDA for aviptadil in patients with Critical COVID-19 who were also treated with remdesivir. The request is based on a post-hoc analysis of around 750 patients and aims to address ongoing respiratory failure. Relief's ongoing collaborations also include a licensing agreement with Acer Therapeutics for another treatment. The PDUFA date for Acer's new drug application is set for June 5, 2022.
- Filing for Breakthrough Therapy Designation could accelerate regulatory approval for aviptadil.
- Cumulative safety data from around 750 patients enhances the credibility of the treatment.
- Ongoing collaboration with Acer Therapeutics on ACER-001 may diversify Relief's product portfolio.
- The outcome of the Breakthrough Therapy Designation request is uncertain.
- Potential legal disputes between Relief and NeuroRx could pose risks to business operations.
Relief Reports that its U.S. Collaboration Partner has Filed a New Breakthrough Therapy Designation Request for Aviptadil in a Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also Treated with Remdesivir and Continued to Progress
GENEVA, SWITZERLAND / ACCESSWIRE / April 22, 2022 / 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, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx"), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"),
has announced that it has filed a new Breakthrough Therapy Designation request with the U.S. Food and Drug Administration ("FDA"). According to NRx, the request was based on a post-hoc analysis, focused on a subgroup of patients with Critical COVID-19 that, in addition to aviptadil or placebo, were also treated with remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress. NRx also reported that the request includes cumulative safety data on approximately 750 patients treated with intravenous aviptadil for Critical COVID-19. 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 drug candidate, RLF-100(R) (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 through Relief's collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, 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. Acer's new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought 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 NeuroRx's recently submitted application to the FDA seeking Breakthrough Therapy Designation for aviptadil focused on a subgroup of patients with Critical COVID-19 that, in addition to aviptadil or placebo, were also treated with remdesivir, will be granted, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's former CEO, Jonathan Javitt, and in defending NeuroRx's recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) 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 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), 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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FAQ
What is the recent FDA filing by Relief Therapeutics regarding aviptadil?
How many patients were involved in the aviptadil study mentioned in the PR?
What is the PDUFA date for Acer Therapeutics's new drug application?
What risks are associated with the Breakthrough Therapy Designation request?
Does Relief have any ongoing collaborations?
