FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19
29.7.2020 08:30:00 EEST | Business Wire | Press release
RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women. Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.1
The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839. Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from expandedaccess@neurorxpharma.com.
“By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO. “We thank the FDA’s pulmonary division for its rapid and proactive implementation of the Coronavirus Treatment Acceleration Program, and we aspire to demonstrate broad safety and efficacy for RLF-100 in our ongoing clinical trial.”
The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.2 Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure. 50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.”3
About RELIEF THERAPEUTICS Holding AG
The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent4 for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF (ISIN: CH0100191136).
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials.
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG 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.
1 Youssef JG, Rapid Clinical Recovery from Critical COVID-19 with Respiratory Failure in a Lung Transplant Patient Treated with Intravenous Vasoactive Intestinal Peptide doi: 10.20944/preprints202007.0178.v1
2 Mason R. Pathogenesis of COVID-19 from a Cell Biologic Perspective. Eur Respir J. April 9 Epub ahead of print. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144II60/
4 US 8,178,489 Formulation for Aviptadil
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200728005828/en/
Contact information
CORPORATE CONTACTS
US Inquiries
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
European Inquiries:
Yves Sagot, Ph.D.
Relief Therapeutics Holding, SA
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Quectel Expands Mid-tier 5G Portfolio with New RedCap 3GPP Release 17 Variants2.3.2026 09:00:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announces the expansion of its 5G RedCap portfolio with the launch of the RM255C-GL for global markets and the RG255C-NA for the North America market, further strengthening its mid-tier 5G offering for worldwide deployments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301754857/en/ Quectel expands mid-tier 5G portfolio with new RedCap 3GPP release 17 variants As 5G expands further into industrial and IoT domains, the need for solutions that combine strong performance with cost efficiency is becoming increasingly critical. Positioned between high-speed eMBB and narrowband NB-IoT, 5G RedCap (Reduced Capability) has emerged as the ideal technology to address this mid-tier connectivity gap. With a comprehensive product portfolio and global deployment expertise, Quectel enables a seamless transition for mid-speed IoT applications moving toward sca
Thales sets a world first in quantum-safe security for 5G networks2.3.2026 09:00:00 EET | Press release
Quantum computing has the potential to break today’s encryption methods in the future, putting mobile communications, personal data and critical infrastructure at risk. For telecom operators, this is not a distant theoretical issue: 5G networks underpin everything from smartphones and connected vehicles to emergency services, industry and national infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301594505/en/ WORLD FIRST: Thales has successfully demonstrated a world-first innovation that prepares 5G networks for the age of quantum computing, marking a major milestone for the global telecommunications industry. (credit photo 123ref) The challenge is scale. Replacing millions of devices every time security standards evolve is neither practical nor sustainable. The industry needs a new approach. With this demonstration, Thales shows that security can be upgraded remotely and instantly, directly on SIM and eSIM
Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera2.3.2026 09:00:00 EET | Press release
Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA. PV is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary tr
NHOA Energy Announces Two Major MACSE Battery Projects2.3.2026 09:00:00 EET | Press release
NHOA Energy, global provider of utility-scale energy storage systems, has been awarded two new Battery Energy Storage System (BESS) projects in Italy by a leading independent platform in the renewables and energy transition sector, with a total MACSE-contracted capacity of about 600 MWh and a total power of 90 MW. The two projects, located in Campania and Sardinia, represent NHOA Energy’s first systems awarded under MACSE (Meccanismo di Approvvigionamento di Capacità di Stoccaggio Elettrico), Italy’s new capacity mechanism dedicated to long-duration storage, and a milestone in the company’s growth in the national energy storage market. The projects, financed by a pool of top-tier Italian and international financial institutions, reaffirm NHOA Energy’s centrality as technology supplier and turnkey contractor in the Italian BESS market, built on extensive local and international experience, breadth of resources, intimate understanding of standards and regulation, and awareness of the eme
Airgain and Nextivity Enter Strategic Partnership on Co-developing Next Generation Integrated 4G / 5G Solutions2.3.2026 08:30:00 EET | Press release
Airgain, Inc. (NASDAQ: AIRG), a leading provider of wireless connectivity solutions, and Nextivity, Inc., an industry leader in intelligent cellular coverage solutions, today announced they have entered into a Strategic Partnership Agreement to collaborate on the development of integrated solutions aimed at improving 4G and 5G coverage across challenging indoor and outdoor environments. The agreement establishes a structured framework for Airgain and Nextivity to jointly define and co-develop integrated coverage solutions that leverage Airgain’s Lighthouse™ 5G Intelligent Node platform and Nextivity’s GO family of intelligent repeaters powered by Nextivity’s IntelliBoost® processor to enhance 4G and 5G coverage solutions beyond the walls of a building. Large Market Opportunity & Accelerated Go‑to‑Market Execution Industry demand for intelligent 4G and 5G coverage-extension solutions continues to accelerate as operators, enterprises, and public safety organizations expand network densif
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom