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
OPEX ® Corporation to Exhibit Advanced Warehouse Automation Solutions at LogiMAT 20264.3.2026 10:00:00 EET | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, will exhibit its latest advancements in warehouse automation at LogiMAT 2026. The world’s largest trade show for intralogistics solutions and process management, LogiMAT will be held March 24 through 26 at the Stuttgart Trade Fair Center in Germany. “Our team looks forward to being onsite at LogiMAT and showcasing several of our leading warehouse automation solutions,” said Alex Stevens, President, Warehouse Automation, OPEX. “We’re proud to deliver cutting-edge systems that help our clients transform how they conduct business, and we appreciate the vast opportunity LogiMAT provides to share our offerings and expertise with event attendees.” At LogiMAT Hall 5 ‒ Stand B25, OPEX will demonstrate Sure Sort® X with Xtract, its award-winning, automated pack-out and order takeaway system. The OPEX Booth will also feature a static display of the company’
Twilio and KPN Partnership Unlocks the Next Generation of Secure Business Messaging in the Netherlands, Powered by Google4.3.2026 10:00:00 EET | Press release
Twilio (NYSE: TWLO), the customer engagement platform that drives real-time, personalised experiences for today’s leading brands, today announced at Mobile World Congress a partnership with KPN Netherlands (KPN) to enable nationwide Rich Communication Services (RCS) Business Messaging across all major mobile operators in the Netherlands, powered by Twilio and Google. RCS Business Messaging combines the simplicity and reach of sms with rich, interactive features such as verified sender identity, images, carousels and action buttons. This allows businesses to communicate in a more engaging, secure and measurable way, strengthening customer trust and improving the overall experience. Enabling nationwide RCS in the Netherlands With nation-wide coverage, KPN plays a central role in the country’s digital infrastructure. By joining the growing RCS ecosystem, this marks a defining moment for business messaging in the Netherlands, making it possible for enterprises to adopt RCS for Business at
SES Brings Satellite Connectivity to Refugees in Chad4.3.2026 09:50:00 EET | Press release
SES, a space solutions company, is expanding humanitarian connectivity at the Farchana refugee settlement in Chad in cooperation with emergency.lu, the public-private partnership led by Luxembourg’s Ministry of Foreign and European Affairs, Defence, Development Cooperation and Foreign Trade and the UN Refugee Agency. In the framework of the Connectivity for Refugees initiative, the deployment uses SES’ O3b mPOWER satellite network to provide dependable, high-speed internet for humanitarian teams and essential services for refugees. This is the first emergency.lu deployment using O3b mPOWER satellites in Medium Earth Orbit (MEO), an expansion beyond the program’s previous use of geostationary (GEO) satellites for rapid disaster-response missions. It also marks a new application for the platform. While emergency.lu has traditionally supported first responders and emergency operations, this deployment is designed to connect refugees and the humanitarian organizations enabling services suc
Travel Smarter: Thales and Airalo Unlock a Seamless Global eSIM Experience4.3.2026 09:00:00 EET | Press release
International travellers have increasingly relied on travel eSIMs to avoid high roaming fees, the hassle of searching for a local SIM card or relying on Wi-Fi hotspots. While this has improved connectivity access for millions, the process in the travel space remains cumbersome, still requiring manual configuration for each trip. By integrating Thales’ eSIM capabilities into its global platform, Airalo, the world’s largest travel eSIM platform, is further enhancing its technical architecture to provide its over 20 million users with a smoother travel experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260303401464/en/ By leveraging Thales’ advanced eSIM solutions, Airalo is further optimizing how travellers access global data. This partnership enhances the Airalo app's underlying technology, providing users with more immediate access to high-quality local networks and a more intuitive experience, so they can stay conne
Kao’s Laurier Launches New Brand Communication Initiative across Asia: Strengthening Global Integration as a Core Brand in Kao’s Asian Business4.3.2026 04:10:00 EET | Press release
Starting on International Women’s Day, March 8, Kao Corporation (TOKYO:4452) will launch new brand communication campaign in nine Asian countries and regions for its feminine sanitary product brand, Laurier, which is the core of its Asian business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260303996141/en/ Laurier Campaign Key Visual Laurier aims to help create more supportive and understanding environments around menstruation, so that women can feel more at ease, both physically and emotionally, under the key message “Comfort, Made Together,” which will be implemented simultaneously across Asia. Kao aims to further develop Laurier as a global brand. Laurier, one of the core brands supporting Kao’s consumer care business in Asia, has been promoting globally integrated operations since 2023. Across all nine Asian countries and regions including Japan, Laurier has been working to unify product specifications and consolida
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