Relief Reports that its U.S. Collaboration Partner has Announced that the I-SPY COVID Trial Suggests No Clinical Benefit with Addition of Nebulized Aviptadil in Critically Ill Patients with COVID-19
Relief Therapeutics Holding SA announced that the I-SPY COVID Trial involving its product aviptadil has been halted due to a lack of clinical benefit in critically ill COVID-19 patients. The Phase 2 trial, sponsored by Quantum Leap Healthcare Collaborative, aimed to evaluate potential agents that could improve recovery times. Relief's pipeline includes RLF-100 and a collaboration with Acer Therapeutics for ACER-001, with a new drug application accepted by the FDA. The future of aviptadil’s approval remains uncertain amid ongoing litigation.
- FDA accepted new drug application for ACER-001, with a PDUFA decision date of June 5, 2022.
- Diverse pipeline from recent acquisitions of APR Applied Pharma Research and AdVita Lifescience.
- I-SPY COVID Trial halted, indicating no clinical benefit for nebulized aviptadil in COVID-19 patients.
- Uncertainty regarding aviptadil's future approval due to ongoing litigation with NRx.
GENEVA, SWITZERLAND / ACCESSWIRE / April 1, 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 "), and Quantum Leap Healthcare Collaborative (" QLHC "), have announced that the nebulized form of aviptadil being used in the I-SPY COVID Trial of critical COVID-19 patients has been stopped. According to NRx and QLHC, the I-SPY COVID Trial (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID Trial. NRx and QLHC reported that the trial is structured to identify those agents with a big impact, those that could have the potential to reduce the time to recovery (defined as reduction in oxygen demand) by approximately
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 EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx's subsidiary, NeuroRx, and NeuroRx's 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 and with the U.S. Securities and Exchange Commission, 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/695619/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-that-the-I-SPY-COVID-Trial-Suggests-No-Clinical-Benefit-with-Addition-of-Nebulized-Aviptadil-in-Critically-Ill-Patients-with-COVID-19
FAQ
What was the outcome of the I-SPY COVID Trial for aviptadil announced by Relief Therapeutics?
What is the significance of the FDA acceptance of ACER-001's application?
What challenges does Relief Therapeutics face regarding aviptadil?
