Relief Reports that its U.S. Collaboration Partner Announces Data Safety Monitoring Board (DSMB) Update on the U.S. National Institutes of Health (NIH) Study of aviptadil in Critical COVID-19
Relief Therapeutics (OTCQB: RLFTF, RLFTY) announced that its collaboration partner, NRx Pharmaceuticals, reported on May 25, 2022, the Data Safety and Monitoring Board's (DSMB) review of the ACTIV-3b (TESICO) trial data. The DSMB determined that evaluation of aviptadil should cease due to futility after reviewing data from approximately 460 patients with Critical COVID-19 Respiratory Failure. This development raises concerns about the viability of aviptadil for treating this condition. Relief is also involved in the FDA filing of ACER-001, with a decision date set for June 5, 2022.
- Collaboration with Acer Therapeutics for ACER-001, which received FDA filing acceptance.
- Diverse pipeline from acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH.
- DSMB halted aviptadil evaluation due to futility after reviewing data from 460 patients in the ACTIV-3b trial, indicating potential challenges for aviptadil's approval.
GENEVA, SWITZERLAND / ACCESSWIRE / May 26, 2022 / 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, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx"), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx"), announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. According to NRx, the DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint. NRx reported that, based on a review of nearly
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® (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 2021 acquisitions 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.
Additional features:
File: Ad hoc release
SOURCE: Relief Therapeutics Holdings AG
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