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
Russell Investments Announces New Long-Term Owners9.7.2026 15:00:00 EEST | Press release
Russell Investments, the global investment solutions provider, today announced that an investor consortium (the “Investor Consortium”) led by B Capital, a global multi-stage investment firm, and including California Public Employees' Retirement System ("CalPERS"), has agreed to acquire the firm from TA Associates (“TA”) and Reverence Capital Partners (“RCP”). The transaction comes as Russell Investments marks over $416 billion in global assets under management (AUM) and has experienced more than 15% organic growth over the past two years. Russell Investments has been a trusted, independent partner to its clients for over 90 years. Its open-architecture model delivers portfolio solutions that source from the full landscape of the asset management industry across public and private markets. With a shared vision for the company’s next phase of growth, the new owners are bringing to Russell Investments long-term capital, advanced technology expertise, and experience scaling next-generation
Esri and Global Partners Release HydroSHEDS v2 for the Americas9.7.2026 15:00:00 EEST | Press release
Esri has made HydroSHEDS v2 publicly available for the first time. Confluvio Consulting led the development of the HydroSHEDS v2 foundational dataset in partnership with the German Aerospace Center (DLR) and Esri, whose geographic information system (GIS) technology will provide users with the data. A major innovation in global hydrographic capabilities, this hydrographic framework is the result of a collaboration initiated by World Wildlife Fund (WWF) and McGill University. HydroSHEDS v2 will support a broad range of applications, including flood risk assessments, freshwater ecosystem conservation, infrastructure planning, water resource management, environmental modeling, scientific research, and operational decision-making. The initial release of HydroSHEDS v2 provides comprehensive hydrographic coverage for North, Central, and South America, and marks the beginning of a phased global rollout. By making these datasets available through ArcGIS Living Atlas, Esri is enabling GIS profe
NIPPON KINZOKU Accelerates Global Sales of Ultra-Thin Electrical Steel Strips "GT Series" and "ST Series" as "Fine Eco Metal" Environmentally Friendly Products9.7.2026 11:01:00 EEST | Press release
NIPPON KINZOKU CO., LTD. (Headquarters: Minato-ku, Tokyo; President: Yasushi Shimokawa; TOKYO: 5491) and its subsidiary, NIKKIN DENJI KOGYO CO., LTD. (Headquarters: Kawaguchi, Saitama; President: Akira Nishimura), are launching a strategic sales initiative for their ultra-thin Grain-Oriented (GT Series) and Non-Oriented (ST Series) electrical steel strips under the brand name "Fine Eco Metal". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709899733/en/ By reducing the thickness of the electrical steel strip, eddy current loss (core loss) can be significantly lowered. Eddy currents are electrical currents generated within the electrical steel strip by alternating magnetic fields; they are a primary factor that increases core loss. "Fine Eco Metal" is a brand name for our proprietary "Eco-Product" series, certified based on our own environmental standards. Background and Objectives: Addressing the "Shift to Electrification
3E Acquires Yordas Group: Expanding Leadership in Product Compliance by Augmenting 3E’s Global Regulatory Content and Expertise, and Adding REACH Registration Services9.7.2026 11:00:00 EEST | Press release
3E, the leading global provider of expert-led AI compliance solutions for chemical and workplace safety, product stewardship, and sustainable supply chains, today announced its acquisition of Yordas Group, a leading international provider of scientific consulting and regulatory content services across chemical management, product stewardship, sustainability, and regulatory compliance. Headquartered in Lancaster, UK, with operations in Germany, Canada, Türkiye, and Japan, Yordas serves global brands through its Scientific Services, Regulatory Intelligence, Product Compliance, and Hazard Communication offerings. Solidifying 3E’s Global Regulatory Content Leadership and Breadth of Expertise The acquisition extends 3E's regulatory content leadership and joins two organizations that pride themselves on building and aligning the industry’s top talent of advanced regulatory and chemical experts. It further solidifies 3E as the product compliance solution provider with the industry's broadest
ROYC and PwC Sweden Collaborate to Digitalize Private Equity Structuring & Fund Operations9.7.2026 11:00:00 EEST | Press release
ROYC today announces a strategic collaboration with PwC Sweden to accelerate the digitalization of the GP value chain. The partnership brings together PwC Sweden's market-leading expertise in fund formation and structuring with ROYC’s platform capabilities, with the shared aim of compressing time-to-market, eliminating manual friction in early-phase workflows, and improving the client experience across the full fund lifecycle for fund managers operating across any jurisdiction. "Digitalization of fund operations is overdue. We work alongside fund managers on structuring decisions, regulatory requirements, and operational complexity every day, and the inefficiencies in the early phase are real and costly. What excites me about this collaboration is the practical ambition behind it: taking the knowledge we apply manually today and making it available through a platform that GPs can use from day one. Working directly with the ROYC team in Stockholm makes iteration fast, and the applicatio
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