16 February 2022
No Notice of Opposition or Extension Request has Been Received in Relation to the Application;
Certificate of Registration Expected by Late April
Geneva, Switzerland, February 16, 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"), has announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board ("DSMB") of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health ("NIH") on February 14, 2022. According to the press release, the DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial. The release reported that no new safety concerns were identified and the study is cleared to continue enrollment to 640 patients. The release also stated that the TESICO protocol was submitted by NIH and cleared by the United States Food and Drug Administration as a phase 3 trial that, if positive, may be used in the submission of a New Drug Application for aviptadil. The related NRx press release can be accessed through the following link.
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 through Relief's collaboration partner in the U.S., NeuroRx, Inc. 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. Finally, 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 symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
RELIEF THERAPEUTICS Holding SA
Chief Financial Officer and Treasurer
Rx Communications Group
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, 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.
File: Ad hoc release
End of ad hoc announcement
|Company:||Relief Therapeutics Holding SA|
|Avenue de Secheron 15|
|Phone:||+41 22 545 11 16|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1280940|
|End of Announcement||EQS News Service|
16 February 2022