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
Multi-Color Corporation Announces Recapitalization to Reset Balance Sheet and Position Company for Long-Term Growth and Investment27.1.2026 23:09:00 EET | Press release
Multi-Color Corporation (“MCC” or the “Company”), a global leader in prime label solutions, today announced strategic actions to further position the Company for long-term growth and investment to best serve its customers. MCC has entered into a restructuring support agreement (the “RSA”) with holders of approximately 70% in amount of MCC’s secured first lien debt and its equity sponsor, CD&R, on the terms of a comprehensive financial restructuring. The transactions contemplated by the RSA will significantly deleverage MCC’s balance sheet, reducing its net debt load from approximately $5.9 billion to approximately $2.0 billion. The Company’s annualized cash interest will also be reduced from approximately $475 million to $140 million in 2026, a reduction of over $330 million, with long-term debt maturities extended to 2033 following consummation of the restructuring transactions. To implement the transactions contemplated by the RSA, MCC has launched a solicitation for votes in support
Logitech Announces Q3 Fiscal Year 2026 Results27.1.2026 23:05:00 EET | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the third quarter of Fiscal Year 2026. Sales were $1.42 billion, up 6 percent in US dollars and 4 percent in constant currency compared to Q3 of the prior year. GAAP gross margin was 43.2 percent, up 30 basis points compared to Q3 of the prior year. Non-GAAP gross margin was 43.5 percent, up 30 basis points compared to Q3 of the prior year. GAAP operating income was $286 million, up 22 percent compared to Q3 of the prior year. Non-GAAP operating income was $312 million, up 17 percent compared to Q3 of the prior year. GAAP earnings per share (EPS) was $1.69, up 28 percent compared to Q3 of the prior year. Non-GAAP EPS was $1.93, up 21 percent compared to Q3 of the prior year. Cash flow from operations was $481 million. The quarter-ending cash balance was $1.8 billion. “We delivered another quarter of excellent financial performance,” sai
Mobileum Launches GlobalRoamer® Connectivity Package for the FIFA World Cup 2026 to Assure Seamless Roaming and 5G Voice Performance Across North America27.1.2026 22:45:00 EET | Press release
Mobileum Inc. (“Mobileum”), a leading global provider of analytics and network solutions, today announced a Special GlobalRoamer® package for the FIFA World Cup 2026, designed to help mobile network operators (MNOs) validate roaming readiness and maintain high-quality connectivity during one of the world’s most demanding network events, where service performance directly impacts roaming revenue, customer retention, and brand reputation. The FIFA World Cup 2026 will place unprecedented pressure on mobile networks across 16 stadiums in the United States, Canada, and Mexico, as millions of fans, teams, media, and officials rely on mobile services to stream, share, and communicate in real time. Sudden spikes in data, voice, and roaming traffic can degrade performance precisely when customer experience is most visible. Mobileum’s FIFA World Cup 2026 package builds on the GlobalRoamer® end-to-end active testing ecosystem used at major global events, including roaming quality campaigns conduc
Tacton Named a Leader in the 2026 Gartner® Magic Quadrant™ for CPQ Applications for the Fourth Consecutive Year27.1.2026 19:00:00 EET | Press release
Tacton, a global leader in Configure, Price, Quote (CPQ) solutions for manufacturers of complex, configurable products, today announced that it has been named a Leader in the 2026 Gartner® Magic Quadrant™ for CPQ Applications. This marks the fourth consecutive year Tacton has been recognized as a Leader in the report. Among the 16 vendors evaluated, Tacton placed highest in the quadrant on Completeness of Vision and for the second consecutive year is positioned highest in Ability to Execute. Tacton CPQ is designed to support manufacturers selling highly configurable products by helping them: Ensure accurate configuration so every quote reflects valid options and constraints Quote faster with confidence across high-variance portfolios without relying on manual engineering checks Maintain pricing and margin control through consistent configuration and pricing logic This approach supports manufacturers as they manage complexity while meeting buyer expectations for speed and accuracy. “We
CSG Recognized in Multi-Category Trusted Analyst Reports for CPQ, Monetization, and Digital Partner Management27.1.2026 18:05:00 EET | Press release
Communication service providers (CSPs) are under pressure to simplify complexity, monetize new services, and deliver experiences customers trust with speed and accuracy. To succeed, they need partners who can turn quote-to-cash and digital monetization into a competitive advantage, not just a back-office function. Over the past year, CSG® (NASDAQ: CSGS) has achieved multi-category recognition from leading analyst firms for doing exactly that. To CSG, these recognitions reinforce a role as a go-to partner for CSPs looking to move faster, unlock new revenue streams, and modernize their core with AI-powered, telco-specific platforms built for real-world complexity. CPQ Leadership for Complex B2B and B2B2X Monetization CSG Quote & Order continues to stand out for CSPs that need to configure complex offers, quote with confidence, and move from deal to revenue without friction. With Quote & Order, CSG is named: A Challenger in the 2026 Gartner® Magic Quadrant™ for Configure, Price & Quote Ap
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